FDA 510(k) Applications for Medical Device:
Pin, Fixation, Smooth
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K221283 | 4WEB Medical, Inc. |
2801 Network Blvd., Suite 620 | Frisco | TX | 75034 |
| K190926 | 4Web, Inc. |
2801 Network Blvd., Suite 620 | Frisco | TX | 75034 |
| K180087 | A.M. Surgical, Inc |
222 Middle Country Road Suite 202 | Smithtown | NY | 11787 |
| K970013 | AAP GMBH AND CO. BETRIEBS KG |
LORENZWEG 5 | 12099 BERLIN | D-1000 | |
| K964500 | ACUMED, INC. |
10950 S.W. 5TH ST. | BEAVERTON | OR | 97005 |
| K160264 | Additive Orthopaedics, LLC |
83 Amelia Circle | Little Silver | NJ | 07739 |
| K960482 | AMERICAN MEDICAL SPECIALTIES, INC. |
6090-H MCDONOUGH DR. | NORCROSS | GA | 30093 |
| K960483 | AMERICAN MEDICAL SPECIALTIES, INC. |
6090-H MCDONOUGH DR. | NORCROSS | GA | 30093 |
| K121004 | APEX TOOLS & ORTHOPEDICS CO. |
1331 H STREET NW 12TH FLOOR | WASHINGTON | DC | 20005 |
| K112254 | APEX TOOLS & ORTHOPEDICS CO. |
25 YONGHUA, YONGHE, | GUANGZHOU, GUANGDONG | CN-511356 | |
| K071616 | ARC SURGICAL LLC. |
21300 NW JACOBSON RD. | HILLSBORO | OR | 97124 |
| K094043 | AREX USA |
1335 MERRYBROOK RD. | COLLEGEVILLE | PA | 19426 |
| K122415 | AREX USA LLC |
1709 HILL ST. | EDGEWATER | FL | 32132 |
| K202777 | Armis Biopharma, Inc. |
2950 East Harmony Road, Suite 252 | Fort Collins | CO | 80528 |
| K100926 | ARROW PRODUCTS, INC. |
2593 LAKE ERMA DRIVE | HAMPTON | GA | 30228 |
| K112675 | ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC |
328 POPLAR VIEW LANE EAST | COLLIERVILLE | TN | 38017 |
| K200068 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K190287 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K100652 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K101837 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K112990 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K050259 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K143702 | Arthrex, Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K991971 | ARTHREX, INC. |
2885 SOUTH HORSESHOE DR. | NAPLES | FL | 34104 |
| K063719 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K052736 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K141577 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K170326 | Arthrex, Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K110123 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K040500 | ARTHROTEK, INC. |
56 EAST BELL DR. | WARSAW | IN | 46582 |
| K014305 | ARTHROTEK, INC. |
P.O. BOX 587 | WARSAW | IN | 46581-0587 |
| K151876 | Bio2 Technologies, Inc |
12R Cabot Road | Woburn | MA | 01801 |
| K091951 | BIOMEDICAL ENT., INC. |
14785 OMICRON DR., SUITE 205 | SAN ANTONIO | TX | 78245 |
| K131640 | BIOMEDICAL ENT., INC. |
14785 OMICRON DR., SUITE 205 | SAN ANTONIO | TX | 78245 |
| K133520 | BIOMEDICAL ENTERPRISES, INC |
14785 OMICRON DR STE 205 | SAN ANTONIO | TX | 78245 |
| K241014 | Biomet, Inc |
56 East Bell Drive | Warsaw | IN | 46581 |
| K022531 | BIOMET, INC. |
56 BELL DR. | WARSAW | IN | 46581-0587 |
| K990291 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K011522 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K003659 | BIONX IMPLANTS, INC. |
HERMIANKATU 6-8 L | TAMPERE | FIN-33720 | |
| K010983 | BIONX IMPLANTS, INC. |
HERMIANKATU 6-8 L | TAMPERE | FIN-33720 | |
| K083490 | BIOPRO, INC. |
17 SEVENTEENTH ST. | PORT HURON | MI | 48060 |
| K061164 | BIORETEC LTD |
HERMIAKATU 22 MODULIGHT BLDG | TAMERE | FI-33720 | |
| K071863 | BIORETEC LTD |
HERMIAKATU 22 MODULIGHT BLDG | TAMERE | FI-33720 | |
| K080879 | BIORETEC LTD |
HERMIAKATU 22 MODULIGHT BLDG | TAMPERE | FI-33720 | |
| K133950 | BIORETEC LTD. |
HERMIANKATU 22, MODULIGTH BUILDING | TAMPERE | FI-33720 | |
| K010479 | BONUTTI RESEARCH, INC. |
2600 SOUTH RANEY | EFFINGHAM | IL | 62401 |
| K033717 | BONUTTI RESEARCH, INC. |
2600 SOUTH RANEY | EFFINGHAM | IL | 62401 |
| K060283 | BONUTTI RESEARCH, INC. |
2600 SOUTH RANEY | EFFINGHAM | IL | 62401 |
| K142134 | CONMED CORPORATION, LARGO |
11311 CONCEPT BLVD | LARGO | FL | 33773 |
| K060654 | DELTA SURGICAL INSTRUMENTS, INC. |
95 SCHUNNEMUNK RD. | HIGHLAND MILLS | NY | 10930 |
| K130105 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K032687 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K960385 | DEPUY, INC. |
700 ORTHOPAEDIC DR. | WARSAW | IN | 46581-0988 |
| K231905 | Electro-Spec, Inc |
1800 Commerce Parkway | Franklin | IN | 46131 |
| K980854 | ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K102215 | EVERGREEN ORTHOPEDIC RESEARCH LAB |
11321 NE 120TH ST | KIRKLAND | WA | 98034 |
| K964087 | FERGUSON MEDICAL |
3407 BAY AVE. | CHICO | CA | 95973-8619 |
| K012161 | FIXANO SA |
P.O BOX 12038 | LA JOLLA | CA | 92039-2038 |
| K024185 | FUTURE MEDICAL SYSTEMS, SA |
504 MCCORMICK DR. | GLEN BURNIE | MD | 21061 |
| K142478 | Graham Medical Technologies, L.L.C. (d.b.a.GraMedica) |
7200 N IH 35 Building #1 | Macomb | MI | 48042 |
| K013424 | HAND INNOVATIONS, INC. |
8905 SW 87TH AVE. | MIAMI | FL | 33176-2227 |
| K041157 | HAND INNOVATIONS, INC. |
8905 SW 87TH AVE. | MIAMI | FL | 33176-2227 |
| K033406 | HAND INNOVATIONS, INC. |
8905 SW 87TH AVE. | MIAMI | FL | 33176-2227 |
| K091955 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K033968 | HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K955806 | HOWMEDICA, INC. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070-2584 |
| K002125 | IMPLANT RESOURCE, INC. |
3150 E. 200TH ST. | PRIOR LAKE | MN | 55372 |
| K173616 | In2Bones SAS |
28 Chemin du Petit Bois | Ecully | 69130 | |
| K153204 | IN2BONES SAS |
28 CHEMIN DU PETIT BOIS | ECULLY | 69130 | |
| K203698 | In2Bones USA, LLC |
6000 Poplar Ave, Suite 115 | Memphis | TN | 38119 |
| K031712 | INION LTD. |
LAAKARINKATU 2 | TAMPERE | 33520 | |
| K050275 | INION LTD. |
LAAKARINKATU 2 | TAMPERE | 33520 | |
| K133932 | INION OY |
LAAKARINKATU 2 | TAMPERE | 33520 | |
| K231147 | Intelivation |
500 S Gravers Rd | Plymouth Meeting | PA | 19462 |
| K061607 | INTELLIGENT ORTHOPAEDICS LTD |
BRIERFIELD MILL | BRIERFIELD, NELSON | BB9 5NJ | |
| K960642 | LANDOS, INC. |
100 LINDENWOOD DR. | MALVERN | PA | 19355 |
| K203475 | Limacorporate S.p.A. |
Via Nazionale, 52 | Villanova di San Daniele | 33038 | |
| K041288 | LINVATEC BIOMATERIALS, INC. |
P.O. BOX 3 | TAMPERE | FIN-33720 | |
| K043106 | LINVATEC CORP. |
11311 CONCEPT BLVD. | LARGO | FL | 33773-4908 |
| K092038 | MEDARTIS AG |
11234 EL CAMINO REAL, STE 200 | SAN DIEGO | CA | 92130 |
| K991064 | MEDCANICA, INC. |
19526 EAST LAKE DR. | MIAMI | FL | 33015 |
| K994232 | MEDCANICA, INC. |
19526 EAST LAKE DR. | MIAMI | FL | 33015 |
| K102072 | MEMOMETAL TECHNOLOGIES |
RUE BLAISE PASCAL | BRUZ | 35170 | |
| K112197 | MEMOMETAL TECHNOLOGIES |
CAMPUS DE KER LANN | BRUZ | F35170 | |
| K070598 | MEMOMETAL TECHNOLOGIES |
RUE BLAISE PASCAL | BRUZ | F35170 | |
| K152627 | METRIC MEDICAL DEVICES, INC. |
846 SILVER SPRINGS | HELOTES | TX | 78023 |
| K013888 | MILTEX, INC. |
700 HICKSVILLE RD. | BETHPAGE | NY | 11714 |
| K974291 | MITEK PRODUCTS |
60 GLACIER DR. | WESTWOOD | MA | 02090 |
| K974341 | MITEK PRODUCTS |
60 GLACIER DR. | WESTWOOD | MA | 02090 |
| K013781 | MITEK PRODUCTS |
249 VANDERBILT AVE. | NORWOOD | MA | 02062 |
| K172485 | Newclip Technics |
PA de la Lande Saint Martin - 45 rue des Garottieres | Haute-Goulaine | 44 115 | |
| K022597 | NEWDEAL S.A. |
9109 COPENHAVER DR. | POTOMAC | MD | 20854 |
| K022599 | NEWDEAL S.A. |
9109 COPENHAVER DR. | POTOMAC | MD | 20854 |
| K103623 | NEWDEAL SAS |
IMMEUBLE SEQUOIA 2, 97 ALLEE | PARC TECHNOLOGIQUE DE LA PRTE | 69800 | |
| K143049 | NOVASTEP |
Espace performance Alphasis - Batiment C1-C2 | Saint Gregoire | 35769 | |
| K250646 | Nvision Biomedical Technologies |
4590 Lockhill Selma Rd | San Antonio | TX | 78249 |
| K012125 | OPUS MEDICAL, INC. |
27127 CALLE ARROYO, SUITE 1924 | SAN JUAN CAPISTRANO | CA | 92675 |
| K031083 | OPUS MEDICAL, INC. |
27127 CALLE ARROYO, SUITE 1924 | SAN JUAN CAPISTRANO | CA | 92675 |
| K173051 | Orthofix Srl |
Via Delle Nazioni 9 | Bussolengo | 37012 | |
| K120165 | ORTHOHELIX SURGICAL DESIGNS, INC. |
1065 Medina Rd. | Medina | OH | 44256 |
| K141004 | ORTHOHELIX SURGICAL DESIGNS, INC. |
1065 Medina Rd. | Medina | OH | 44256 |
| K201838 | OrthoPediatrics Corp. |
2850 Frontier Drive | Warsaw | IN | 46582 |
| K251362 | OrthoPediatrics Corp. |
2850 Frontier Dr. | Warsaw | IN | 46582 |
| K082375 | ORTHOPEDIATRICS, CORP. |
210 N. BUFFALO ST. | WARSAW | IN | 46580 |
| K081097 | ORTHOPEDIATRICS, LLC |
210 NORTH BUFFALO STREET | WARSAW | IN | 46580 |
| K070555 | ORTHOPRO LLC |
13115 NE 4TH ST., SUITE 130 | VANCOUVER | WA | 98684 |
| K971453 | ORTHOTECH |
1053 KOLOA ST. | HONOLULU | HI | 96816 |
| K203465 | OSSIO Ltd. |
8 HaTochen St. | Caesarea | 3079861 | |
| K230750 | Ossio Ltd. |
8 HaTochen St. | Caesarea | 3079861 | |
| K231272 | OSSIO Ltd. |
8 HaTochen St. | Caesarea | 3079861 | |
| K190652 | Ossio Ltd. |
8 HaTochen St. | Caesarea | 3079861 | |
| K201803 | Ossio Ltd. |
8 HaTochen St. | Caesarea | 3079861 | |
| K181180 | Ossio Ltd. |
8 HaTochen St. | Caesarea | 3088900 | |
| K971962 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K213982 | Pacific Instruments |
438 Hobron Ln, Ste 204 | Honolulu | HI | 96815 |
| K171715 | Paragon 28 |
4B Inverness Ct. E., STE 280 | Englewood | CO | 80112 |
| K183228 | Paragon 28, Inc. |
4B Inverness Ct. E, STE 280 | Englewood | CO | 80112 |
| K160194 | Phalanx Innovations |
200 Cobb Pkw N, Bldg 200, Ste 210 | Marietta | GA | 30062 |
| K163327 | PRECIFIT MEDICAL LTD |
951 AVIATION PKWY STE 100 | MORRISVILLE | NC | 27560 |
| K211789 | restor3d |
311 W. Corporation St. | Durham | NC | 27701 |
| K963367 | RMS DIV. |
8600 EVERGREEN BLVD. | MINNEAPOLIS | MN | 55433-6036 |
| K073674 | SIGNAL MEDICAL CORP. |
400 PYRAMID DR. | MARYSVILLE | MI | 48040 |
| K211439 | Skeletal Dynamics, Inc. |
7300 N. Kendall Drive, Suite 400 | Miami | FL | 33156 |
| K051605 | SMALL BONE INNOVATIONS, LLC |
1711 S. PENNSYLVANIA AVENUE | MORRISVILLE | PA | 19067 |
| K041355 | SMITH & NEPHEW, INC. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K100736 | SMT SCHILLING METALLTECHNIK GMBH |
GRIESWEG 47 | MUEHLHEIM, BADEN-WURTTEMBERG | 78570 | |
| K152662 | Spinal Resources Inc |
274 E Eau Gallie Blvd Unit 303 | Indian Harbour Beach | FL | 32937 |
| K082017 | STARR FRAME LLC |
1302 E. COLLINS BLVD. | RICHARDSON | TX | 75081 |
| K030665 | STORK INSTRUMENTE GMBH |
7046 BENTLY DR. | GURNEE | IL | 60031 |
| K150416 | STRYKER ENDOSCOPY |
5900 OPTICAL COURT | SAN JOSE | CA | 95138 |
| K201715 | Stryker GmbH |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K170418 | Stryker Trauma Gmbh |
Prof-Kuentscher-Str. 1-5 | Schoenkirchen | 24232 | |
| K143063 | STRYKER TRAUMA GMBH |
325 Corporate | Mahwah | NJ | 07430 |
| K982719 | SURGICRAFT LTD. |
FISHING LINE RD. | REDDITCH, WORCS. | B97 6HF | |
| K133477 | SYNCHRO MEDICAL |
505 BERKS PLACE | WEST LAWN | PA | 19609 |
| K983121 | SYNTEC SCIENTIFIC CORP. |
2, KUNG SAN ROAD, CHAUN SHING | CHANG HUA | 509 | |
| K003527 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K961608 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K971783 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K973240 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K970733 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K161489 | SYNTORR INC |
1157 HARKER AVENUE | PALO ALTO | CA | 94301 |
| K961522 | SYNVASIVE TECHNOLOGY, INC. |
4925 ROBERT J. MATHEWS PKWY. | EL DORADO HILLS | CA | 95762 |
| K073311 | TAKIRON CO., LTD |
7-1-19, MINATOJIMAMINAMIMACHI, | CHUO-KU, KOBE, HYOGO | 650-0047 | |
| K070561 | TELEFLEX MEDICAL |
2345 WAUKEGAN ROAD | BANNOCKBURN | IL | 60015 |
| K121008 | TRILLIANT SURGICAL LTD |
6721 Portwest Dr Ste 160 | Houston | TX | 77024 |
| K231339 | Tyber Medical, LLC |
83 South Commerce Way | Bethlehem | PA | 18017 |
| K970036 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. | NORWALK | CT | 06856 |
| K110047 | VERTICOR, LTD |
1001 OAKWOOD BLVD. | ROUND ROCK | TX | 78681 |
| K173013 | WishBone Medical, Inc. |
2150 North Pointe Drive | Warsaw | IN | 46582 |
| K141714 | WRIGHT MEDICAL TECHNOLOGY, INC. |
1023 CHERRY ROAD | MEMPHIS | TN | 38117 |
| K132895 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K220906 | Xiros Ltd |
Springfield House Lane, Whitehouse Lane | Leeds | LS17 7UE | |
| K043339 | XTREMI-T, LLC |
3131 PRINCETON PIKE, BLDG. 5 | LAWRENCEVILLE | NJ | 08648 |
| K143618 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K150626 | Zimmer, Inc. |
P.O. Box 708 | Warsaw | IN | 46581 |
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