FDA 510(k) Applications for Medical Device:
Fastener, Fixation, Biodegradable, Soft Tissue

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K200725 Acuitive Technologies 50 Commerce Drive
Allendale NJ 07401
K220833 Acuitive Technologies, Inc. 50 Commerce Drive
Allendale NJ 07401
K221468 Acuitive Technologies, Inc. 50 Commerce Drive
Allendale NJ 07401
K210239 Acuitive Technologies, Inc. 50 Commerce Drive
Allendale NJ 07401
K203334 Acuitive Technologies, Inc. 50 Commerce Drive
Allendale NJ 07401
K070178 AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway
Center Valley PA 18034
K230892 Aju Pharm Co., Ltd. A-207, 697, Pangyo-ro
Seongnam 13511
K192484 AJU Pharm Co., Ltd. A-207, 697, Pangyo-ro
Seongnam-si 13511
K192032 AJU Pharm Co., Ltd. A-207, 697, Pangyo-ro
Seongnam-si 13511
K203523 AJU Pharm Co., Ltd. A-207, 697, Pangyo-ro
Seongnam-si 13511
K171299 AJU Pharm Co.,Ltd. A-207, 697, Pangyo-ro
Seongnam-si 13511
K193157 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K221128 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K173788 Arthrex Inc. 1370 Creekside Boulevard
Napes FL 34108-1945
K180662 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K202535 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K201786 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K173240 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K222263 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108
K221099 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K203495 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108
K192532 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K201749 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K180768 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K192441 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-5553
K171141 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 71924
K191226 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K193503 Arthrex Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K230435 Arthrex, Inc. 1370 Creekside Boulevard
Naples FL 34113
K082810 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K091844 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K011495 ARTHREX, INC. 2885 SOUTH HORSESHOE DR.
NAPLES FL 34104
K110660 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K112040 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K062466 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K983577 ARTHREX, INC. 2885 SOUTH HORSESHOE DR.
NAPLES FL 34104
K082999 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K990340 ARTHREX, INC. 2885 SOUTH HORSESHOE DR.
NAPLES FL 34104
K071456 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K101679 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K140855 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K101823 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K151342 ARTHREX, INC. 1370 CREEKSIDE BOULEVARD
NAPLES FL 34108-1945
K003227 ARTHREX, INC. 2885 SOUTH HORSESHOE DR.
NAPLES FL 34104
K990987 ARTHREX, INC. 2885 SOUTH HORSESHOE DR.
NAPLES FL 34104
K983843 ARTHREX, INC. 2885 SOUTH HORSESHOE DR.
NAPLES FL 34104
K000506 ARTHREX, INC. 2885 SOUTH HORSESHOE DR.
NAPLES FL 34104
K971358 ARTHREX, INC. 555 THIRTEENTH ST., N.W.
WASHINGTON DC 20004-1109
K120540 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K990361 ARTHREX, INC. 2885 SOUTH HORSESHOE DR.
NAPLES FL 34104
K180594 Arthrex, Inc. 1370 Creekside Boulevard
Naples FL 34108-1945
K071176 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K051219 ARTHREX, INC. 1370 CREEKSIDE BLVD.
NAPLES FL 34108-1945
K041698 AXYA MEDICAL, INC. 100 CUMMINGS CENTER
BEVERLY MA 01915
K051250 AXYA MEDICAL, INC. 100 CUMMINGS CENTER
BEVERLY MA 01915
K051983 AXYA MEDICAL, INC. 100 CUMMINGS CENTER
BEVERLY MA 01915
K212912 b-ONE ORTHO, Corp 3 Wing Drive Suite #259
Cedar Knolls NJ 07927
K053492 BIODUCT, LLC 3201 STELLHORN ROAD
FORT WAYNE IN 46815
K002020 BIOMET MANUFACTURING, INC. 56 EAST BELL DR.
WARSAW IN 46581-0587
K982095 BIOMET, INC. AIRPORT INDUSTRIAL PARK,
WARSAW IN 46581-0587
K003273 BIOMET, INC. AIRPORT INDUSTRIAL PARK,
WARSAW IN 46581-0587
K991009 BIOMET, INC. AIRPORT INDUSTRIAL PARK,
WARSAW IN 46581-0587
K001378 BIONX IMPLANTS, INC. HERMIANKATU 6-8 L
TAMPERE FIN-33720
K013057 BIONX IMPLANTS, INC. HERMIANKATU 6-8 L
TAMPERE FIN-33720
K972783 BIONX IMPLANTS, INC. 555 13TH STREET, N.W.
WASHINGTON DC 20004
K974876 BIONX IMPLANTS, INC. 555 13TH STREET, N.W.
WASHINGTON DC 20004
K003970 BIONX IMPLANTS, INC. HERMIANKATU 6-8 L
TAMPERE FIN-33720
K012334 BIONX IMPLANTS, INC. HERMIANKATU 6-8 L
TAMPERE FIN-33720
K992567 BIONX IMPLANTS, LTD. P.O. BOX 3
TAMPERE SP-33721
K993453 BIONX IMPLANTS, LTD. P.O. BOX 3
TAMPERE SP-33721
K993074 BIONX IMPLANTS, LTD. P.O. BOX 3
TAMPERE SP-33721
K993073 BIONX IMPLANTS, LTD. P.O. BOX 3
TAMPERE SP-33721
K000616 BIONX IMPLANTS, LTD. HERMIANKATU 6-8 L
TAMPERE FIN-33720
K130716 BIORETEC LTD HERMIANKATU 22 MODULIGHT BLDG
TAMPERE FI-33720
K955768 BIOSCIENCE, INC. 555 THIRTEENTH ST. NW
WASHINGTON DC 20004-1109
K955003 BIOSCIENCE, INC. 555 THIRTEENTH ST. NW
WASHINGTON DC 20004-1109
K052799 BONUTTI RESEARCH, INC. P O BOX 1367
EFFINGHAM IL 62401
K012465 BONUTTI RESEARCH, INC. P.O. BOX 1367
EFFINGHAM IL 62401
K993115 BONUTTI RESEARCH, INC. 2600 SOUTH RANEY
EFFINGHAM IL 62401
K170501 ConMed Corporation 525 French Road
Utica NY 13502
K171592 ConMed Corporation 525 French Road
Utica NY 13502
K180763 CONMED Corporation 525 French Road
Utica NY 13502
K092898 CONMED LINVATEC 11311 CONCEPT BOULEVARD
LARGO FL 33773-4908
K101100 CONMED LINVATEC 11311 CONCEPT BOULEVARD
LARGO FL 33773-4908
K120078 DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY 325 Paramount Drive
Raynham MA 02767
K133794 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K103831 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K132241 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K141259 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K073412 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K090124 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K100012 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K130917 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K131974 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K113534 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K112249 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K143660 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K120589 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K122869 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K070925 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K040827 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT DR.
NORWOOD MA 02062
K091041 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K090669 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR.
RAYNHAM MA 02767
K140643 DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive
Raynham MA 02767
K150209 Depuy Mitek, a Johnson and Johnson Company 325 Paramount Drive
Raynham MA 02767
K964521 DEPUY, INC. 700 ORTHOPAEDIC DR.
WARSAW IN 46581-0988
K982900 DEPUY, INC. P.O. BOX 988
WARSAW IN 46581-0988
K990999 ELECTRO-BIOLOGY, INC. 100 INTERPACE PKWY.
PARSIPPANY NJ 07054
K213958 Embody, Inc. 4211 Monarch Way, Suite 500
Norfolk VA 23508
K970896 ETHICON, INC. P.O BOX 151, ROUTE 22 WEST
SOMERVILLE NJ 08876
K952687 ETHICON, INC. P.O BOX 151, ROUTE 22 WEST
SOMERVILLE NJ 08876
K973849 HOGAN & HARTSON 555 THIRTEENTH STREET, N.W.
WASHINGTON DC 20004-1109
K051362 INION OY LAAKARINKATU 2
TAMPERE FIN-33520
K062782 INION OY LAAKARINKATU 2
TAMPERE 33520
K973381 INNOVASIVE DEVICES, INC. 734 FOREST ST.
MARLBOROUGH MA 01752
K981340 INNOVASIVE DEVICES, INC. 734 FOREST ST.
MARLBOROUGH MA 01752
K984490 INNOVASIVE DEVICES, INC. 734 FOREST ST.
MARLBOROUGH MA 01752
K994269 INNOVASIVE DEVICES, INC. 734 FOREST ST.
MARLBOROUGH MA 01752
K960555 INSTRUMENT MAKAR, INC. C/O ABOOD,ABOOD & RHEAUME,P.C.
LANSING MI 48933
K963396 INSTRUMENT MAKAR, INC. C/O ABOOD,ABOOD & RHEAUME,P.C.
LANSING MI 48933
K944544 JOHNSON & JOHNSON PROFESSIONALS, INC. 20 LAKE DR.
EAST WINDSOR NJ 08520
K983435 LI MEDICAL TECHNOLOGIES, INC. 4 ARMSTRONG RD.
SHELTON CT 06484
K992938 LI MEDICAL TECHNOLOGIES, INC. 4 ARMSTRONG RD.
SHELTON CT 06484
K993373 LI MEDICAL TECHNOLOGIES, INC. 4 ARMSTRONG RD.
SHELTON CT 06484
K002413 LI MEDICAL TECHNOLOGIES, INC. 4 ARMSTRONG RD.
SHELTON CT 06484
K031981 LINVATEC BIOMATERIALS, LTD. 1311 CONCEPT BLVD
LARGO FL 33773
K042966 LINVATEC BIOMATERIALS, LTD. HERMIANKATU 6-8L
TAMPERE
K955486 LINVATEC CORP. 11311 CONCEPT BLVD.
LARGO FL 33773-4908
K963369 LINVATEC CORP. 11311 CONCEPT BLVD.
LARGO FL 33773-4908
K964805 LINVATEC CORP. 11311 CONCEPT BLVD.
LARGO FL 33773-4908
K983186 LINVATEC CORP. 11311 CONCEPT BLVD.
LARGO FL 33773-4908
K991715 LINVATEC CORP. 11311 CONCEPT BLVD.
LARGO FL 33773-4908
K090835 LINVATEC CORP. 11311 CONCEPT BLVD.
LARGO FL 33773-4908
K090186 LINVATEC CORP. 11311 CONCEPT BLVD.
LARGO FL 33773-4908
K984171 LINVATEC CORP. 11311 CONCEPT BLVD.
LARGO FL 33773-4908
K993339 LINVATEC CORP. 11311 CONCEPT BLVD.
LARGO FL 33773-4908
K003984 LINVATEC CORP. 11311 CONCEPT BLVD.
LARGO FL 33773-4908
K041128 LINVATEC CORP. 11311 CONCEPT BLVD.
LARGO FL 33773-4908
K121890 LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard
LARGO FL 33773
K203493 Medacta International SA Strada Regina
Castel San Pietro CH-6874
K181809 Medos International SARL Chemin-Blanc 38, Case Postale
Le Locle CH 2400
K173859 Medos International SARL Chemin-Blanc 38, Case Postale
Le Locle CH 2400
K183506 Medos International SARL Chemin-Blanc 38, Case Postale
Le Locle CH 2400
K170639 Medos International SARL Chemin-Blanc 38, Case Postale
Le Locle CH 2400
K171114 Medos International SARL Chemin-Blanc 38, Case Postale
Le Locle CH 2400
K180101 Medos International SARL Chemin-Blanc 38, Case Postale
Le Locle CH 2400
K191242 Medos International SARL Chemin-Blanc 38, Case Postale
Le Locle CH 2400
K160804 MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38, CASE POSTALE
LE LOCLE CH 2400
K002406 MITEK PRODUCTS 249 VANDERBILT AVE.
NORWOOD MA 02062
K964013 MITEK PRODUCTS 60 GLACIER DR.
WESTWOOD MA 02090
K003076 MITEK PRODUCTS 249 VANDERBILT AVE.
NORWOOD MA 02062
K031519 MITEK WORLDWIDE A JOHNSON & JOHNSON COMPANY
NORWOOD MA 02062
K183236 Nanofiber Solutions, LLC 4389 Weaver Court North
Hilliard OH 43026
K201414 Nanofiber Solutions, LLC 4389 Weaver Ct. N.
Hilliard OH 43026
K231641 Nanofiber Solutions, LLC 5164 Blazer Parkway
Dublin OH 43017
K161174 NANOVA BIOMATERIALS INC. 3806 MOJAVE CT
COLUMBIA MO 65202
K163672 NANOVA BIOMATERIALS, INC. 3806 MOJAVE CT
COLUMBIA MO 65202
K213415 OSSIO Ltd. 8 HaTochen St.
Caesarea 3079861
K202806 OSTEONIC Co., Ltd. 39 Digital-ro 29-gil
Guro-gu 08381
K231326 Osteonic Co., Ltd. 1206Ho, 38, Digital-ro, 29-gil, Guro-gu
Seoul 08381
K210122 Osteonic Co., Ltd. 39 Digital-ro 29-gil
Guro-gu 08381
K232513 Parcus Medical 6455 Parkland Drive
Sarasota FL 34243
K192824 Parcus Medical, LLC 6423 Parkland Dr
Sarasota FL 34243
K183501 Parcus Medical, LLC 6423 Parkland Dr
Sarasota FL 34231
K170868 S.B.M SAS Science for Bio Materials ZI du Monge
Lourdes 65100
K180960 S.B.M. SAS Sciences for Bio Materials ZI du Monge
Lourdes 65100
K122228 SBM SCIENCES FOR BIO MATERIALS ZI DU MONGE
LOURDES 65100
K063497 SCANDIUS BIOMEDICAL, INC. 11A BEAVER BROOK ROAD
LITTLETON MA 01460
K060522 SCANDIUS BIOMEDICAL, INC. 11A BEAVER BROOK ROAD
LITTLETON MA 01460
K231787 Science & Bio materials (S.B.M.) SAS Zi Du Monge
Lourdes 65100
K103309 SMITH & NEPHEW ENDOSCOPY, INC. 150 Minuteman Road
Andover MA 01810
K102982 SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 MINUTEMAN RD.
ANDOVER MA 01810
K142948 Smith & Nephew, Inc 150 Minuteman Dr
Andover MA 01810
K143172 SMITH & NEPHEW, INC. 150 MINUTEMAN RD.
ANDOVER MA 01810
K193558 Smith & Nephew, Inc. 7135 Goodlett Farms Parkway
Cordova TN 38016
K123393 SMITH & NEPHEW, INC. 150 MINUTEMAN RD.
ANDOVER MA 01810
K101459 SMITH & NEPHEW, INC. 150 MINUTEMAN RD.
ANDOVER MA 01810
K011985 SMITH & NEPHEW, INC. 160 DASCOMB RD.
ANDOVER MA 01810
K093844 SMITH & NEPHEW, INC. 130 FORBES BLVD.
MANSFIELD MA 02048
K011299 SMITH & NEPHEW, INC. 160 DASCOMB RD.
ANDOVER MA 01810
K151105 Smith & Nephew, Inc. 130 Forbes Boulevard
Mansfield MA 02048
K032197 SMITH & NEPHEW, INC. 130 FORBES BLVD.
MANSFIELD MA 02048
K180361 Smith and Nephew, Inc 7135 Goodlett Farms Parkway
Cordova TN 38016
K181746 Smith and Nephew, Inc. 7135 Goodlett Farms Parkway
Cordova TN 38016
K171228 SportWelding GmbH Wagistrasse 6
Schlieren 8952
K041307 Stryker Endoscopy 5900 OPTICAL CT.
SAN JOSE CA 95138
K041305 Stryker Endoscopy 5900 OPTICAL CT.
SAN JOSE CA 95138
K993061 STRYKER INSTRUMENTS 4100 EAST MILHAM AVE.
KALAMAZOO MI 49001
K994161 SYNTHES (USA) P.O. BOX 1766
PAOLI PA 19301-1222
K003743 SYNTHES (USA) 1690 RUSSELL RD.
PAOLI PA 19301
K230394 Teknimed 11 rue Apollo
L'Union 31240
K122635 TORNIER, INC. 10801 NESBITT AVENUE
BLOOMINGTON MN 55437
K083268 TORNIER, INC. 100 CUMMINGS CENTER
BEVERLY MA 01915
K965228 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE.
NORWALK CT 06856
K973281 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE.
NORWALK CT 06856
K961789 ZIMMER, INC. P.O. BOX 708
WARSAW IN 46581-0708
K162429 ZIPTEK, LLC 1250 S TAMIAMI TRL STE 303
Sarasota FL 34239-2221




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