FDA 510(k) Applications for Medical Device:
Staple, Fixation, Bone
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K961555 | ACUFEX MICROSURGICAL, INC. |
130 FORBES BLVD. | MANSFIELD | MA | 02048 |
| K172052 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K203180 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K080111 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K061801 | ARTHROTEK, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K061389 | ARTHROTEK, INC. |
P.O. BOX 587 | WARSAW | IN | 46581-0587 |
| K061776 | ARTHROTEK, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K061657 | ARTHROTEK, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K161587 | AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT |
212 COPPERWOOD COURT | MILLERSVILLE | MD | 21108 |
| K003033 | AVANTA ORTHOPAEDICS, INC. |
9369 CARROLL PARK DRIVE, STE.A | SAN DIEGO | CA | 92121 |
| K060970 | AXYA MEDICAL, INC. |
100 CUMMINGS CENTER | BEVERLY | MA | 01915 |
| K993714 | BIOMEDICAL ENT., INC. |
14785 OMICRON DR., SUITE 205 | SAN ANTONIO | TX | 78245 |
| K001354 | BIOMEDICAL ENT., INC. |
14785 OMICRON DR., SUITE 205 | SAN ANTONIO | TX | 78245 |
| K023203 | BIOMEDICAL ENT., INC. |
14785 OMICRON DR., SUITE 205 | SAN ANTONIO | TX | 78245 |
| K102107 | BIOMEDICAL ENT., INC. |
14785 OMICRON DR., SUITE 205 | SAN ANTONIO | TX | 78245 |
| K133844 | BIOMEDICAL ENT., INC. |
14785 OMICRON DR., SUITE 205 | SAN ANTONIO | TX | 78245 |
| K133780 | BIOMEDICAL ENT., INC. |
14785 OMICRON DR., SUITE 205 | SAN ANTONIO | TX | 78245 |
| K133270 | BIOMEDICAL ENTERPRISES, INC |
14785 OMICRON DR STE 205 | SAN ANTONIO | TX | 78245 |
| K124022 | BIOMEDICAL ENTERPRISES, INC |
14785 OMICRON DR STE 205 | SAN ANTONIO | TX | 78245 |
| K150125 | BioMedical Enterprises, Inc. |
14785 Omicron Dr., Suite 205 | San Antonio | TX | 78245 |
| K142292 | BioMedical Enterprises, Inc. |
14785 Omicron Dr., | San Antonio | TX | 78245 |
| K081172 | BIOMET MANUFACTURING CORP. |
PO BOX 587 | WARSAW | IN | 46581-0587 |
| K143037 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46581-0587 |
| K151615 | BIOMET MANUFACTURING CORP. |
56 BELL DRIVE | WARSAW | IN | 46580 |
| K141263 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46581-0587 |
| K041988 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K981798 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K061798 | BIOPRO, INC. |
17 SEVENTEENTH ST. | PORT HURON | MI | 48060 |
| K072298 | BIOPRO, INC. |
17 SEVENTEENTH ST. | PORT HURON | MI | 48060 |
| K071477 | CORE ESSENCE ORTHOPAEDICS, LLC |
301 OXFORD VALLEY RD. | YARDLEY | PA | 19067 |
| K190722 | CrossRoads Extemity Systems, LLC |
6055 Primacy Pkwy Suite 140 | Memphis | TN | 38119 |
| K181410 | CrossRoads Extremity Systems, LLC |
6055 Primacy Parkway, Suite 140 | Memphis | TN | 38119 |
| K181866 | CrossRoads Extremity Systems, LLC |
6055 Primacy Pkwy, Suite 140 | Memphis | TN | 38119 |
| K122871 | DALLEN MEDICAL, INC. |
1046 Calle Recodo Ste G | San Clemente | CA | 92673 |
| K132875 | DALLEN MEDICAL, INC. |
1046 Calle Recodo Ste G | San Clemente | CA | 92673 |
| K140358 | DALLEN MEDICAL, INC. |
1046 Calle Recodo Ste G | San Clemente | CA | 92673 |
| K171473 | Dallen Medical, Inc. |
1046 Calle Recodo, Suite G | San Clemente | CA | 92673 |
| K063273 | DEPUY MILTEK, A JOHNSON & JOHNSON CO. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K041064 | Depuy Mitek |
249 VANDERBILT DR. | NORWOOD | MA | 02062 |
| K041065 | Depuy Mitek |
249 VANDERBILT DR. | NORWOOD | MA | 02062 |
| K041117 | Depuy Mitek |
249 VANDERBILT DR. | NORWOOD | MA | 02062 |
| K041116 | Depuy Mitek |
249 VANDERBILT AVE. | NORWOOD | MA | 02062 |
| K062170 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K073281 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K041115 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
249 VANDERBILT AVE. | NORWOOD | MA | 02062 |
| K051989 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
249 VANDERBILT AVE. | NORWOOD | MA | 02062 |
| K071257 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K060553 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K052631 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
249 VANDERBILT AVE. | NORWOOD | MA | 02062 |
| K060746 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K163226 | Epic Extremely, LLC |
120 Marguerite Dr, Ste 301 | Cranberry Twp | PA | 16066 |
| K950272 | ETHICON, INC. |
ROUTE 22 WEST | SOMERVILLE | NJ | 08876-0151 |
| K172205 | ExoToe LLC |
Po Box 548 | Grimes | IA | 50111 |
| K173775 | F & A Foundation LLC d.b.a. Reign Medical |
6303 E 102nd Street Suite 200 | Tulsa | OK | 74137 |
| K153622 | FIRST RAY LLC |
124 SOUTH 600 WEST, SUITE 100 | LOGAN | UT | 84321 |
| K163440 | FIRST RAY LLC |
124 SOUTH 600 WEST, SUITE 100 | LOGAN | UT | 84321 |
| K181815 | Fusion Orthopedics, LLC |
4135 S. Power Rd., Suite 110 | Mesa | AZ | 85212 |
| K182212 | Gramercy Extremity Orthopedics, LLC |
1239 N. Glenville Dr | Richardson | TX | 75081 |
| K991962 | GROUPE LEPINE |
962 SOUTH TAMIAMI TRAIL | SARASOTA | FL | 34326 |
| K965175 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K031127 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K153395 | IN2BONES SAS |
28 CHEMIN DU PETIT BOIS | ECULLY | 63130 | |
| K143323 | IN2Bones SAS |
28 CHEMIN DU PETIT BOIS | ECULLY | 63130 | |
| K153770 | IN2BONES SAS |
28 CHEMIN DU PETIT BOIS | ECULLY | 69130 | |
| K161426 | IN2BONESUSA, LLC |
6060 POPLAR AVE, SUITE 380 | MEMPHIS | TN | 38119 |
| K133523 | INSTRATEK, INC. |
15200 Middlebrook Dr Ste G | Houston | TX | 77058 |
| K051408 | INTELIFUSE, INC. |
5582 CHALON ROAD | YORBA LINDA | CA | 92886 |
| K060014 | INTELIFUSE, INC. |
5582 CHALON ROAD | YORBA LINDA | CA | 92886 |
| K071637 | INTRINSIC THERAPEUTICS INCORPORATED |
30 COMMERCE WAY | WOBURN | MA | 01801 |
| K964226 | LANDOS, INC. |
9109 COPENHAVER DR. | POTOMAC | MD | 20854 |
| K210456 | Medacta International SA |
Strada Regina | Castel San Pietro | CH-6874 | |
| K191636 | Medartis AG |
Hochbergerstrasse 60E | Basel | CH-4057 | |
| K232324 | Medartis Inc. |
1195 Polk Drive | Warsaw | IN | 46582 |
| K962705 | MEDICINE LODGE, INC. |
819 STRIKER AVE., SUITE 10 | SACRAMENTO | CA | 95834-5432 |
| K102387 | MEDISCOPE MANUFACTURING, INC. |
8282 SHADOW WOOD BLVD | POMPANO BEACH | FL | 33069 |
| K210482 | Medline Industries, Inc. |
Three Lakes Drive | Northfield | IL | 60093 |
| K231885 | Medline Industries, LP |
Three Lakes Drive | Northfield | IL | 60093 |
| K193305 | MedShape, Inc. |
1575 Northside Drive NW, Suite 440 | Atlanta | GA | 30318 |
| K220812 | MedShape, Inc. |
1575 Northside Dr. NW, Suite 440 | Atlanta | GA | 30318 |
| K181781 | MedShape, Inc. |
1575 Northside Drive, Suite 440 | Atlanta | GA | 30318 |
| K012081 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K070031 | MEMOMETAL TECHNOLOGIES |
RUE BLAISE PASCAL | BRUZ | F35170 | |
| K070033 | MEMOMETAL TECHNOLOGIES |
RUE BLAISE PASCAL | BRUZ | F35170 | |
| K151762 | MERETE MEDICAL GMBH |
ALT-LANKWITZ 102 | BERLIN | 12247 | |
| K123926 | METASURG |
SUITE 100 | HOUSTON | TX | 77084 |
| K123363 | METRIC MEDICAL DEVICES, INC. |
846 SILVER SPRINGS | HELOTES | TX | 78023 |
| K962793 | MITEK PRODUCTS |
60 GLACIER DR. | WESTWOOD | MA | 02090 |
| K982420 | MITEK PRODUCTS |
60 GLACIER DR. | WESTWOOD | MA | 02090 |
| K021953 | MITEK WORLDWIDE |
249 VANDERBILT AVE. | NORWOOD | MA | 02062 |
| K023388 | MITEK WORLDWIDE |
249 VANDERBILT AVE. | NORWOOD | MA | 02062 |
| K143622 | MX Orthopedics, Corp. |
12 Suburban Park Drive | Billerica | MA | 01821 |
| K153129 | MX Orthopedics, Corp. |
1 Broadway, 14th Floor | Cambridge | MA | 02142 |
| K192447 | Neosteo |
Malleve 2A, 1 Boulevard Jean Moulin | Nantes | 44 100 | |
| K061594 | NEWDEAL S.A. |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K991566 | NEWDEAL S.A. |
9109 COPENHAVER DR. | POTOMAC | MD | 20854 |
| K011716 | NEWDEAL S.A. |
9109 COPENHAVER DR. | POTOMAC | MD | 20854 |
| K991482 | NEWDEAL S.A. |
9109 COPENHAVER DR. | POTOMAC | MD | 20854 |
| K070688 | NEXA ORTHOPEDICS, INC. |
11035 ROSELLE STREET | SAN DIEGO | CA | 92121 |
| K131061 | NEXTREMITY SOLUTIONS |
54 Broad St Ste 200 | Red Bank | NJ | 07701 |
| K151160 | NEXTREMITY SOLUTIONS, INC. |
54 BROAD STREET, STE 200 | RED BANK | NJ | 07701 |
| K220181 | Nextremity Solutions, Inc. |
1195 Polk Drive | Warsaw | IN | 46582 |
| K142111 | NOVATSEP |
ESPACE PERFORMANCE ALPHASIS-BATIMENT C1-C2 | SAINT GREGOIRE | 35769 | |
| K182943 | Nvision Biomedical Technologies, LLC |
4754 Shavano Oak, Suite 101 | San Antonio | TX | 78249 |
| K142727 | OrthoDiscovery Group LLC(D.B.A. CrossRoads Extremity Systems |
458 DISTRIBUTION PKWY | COLLIERVILLE | TN | 38017 |
| K142148 | ORTHOHELIX SURGICAL DESIGNS, INC. |
1065 Medina Rd. | Medina | OH | 44256 |
| K130832 | ORTHOHELIX SURGICAL DESIGNS, INC. |
1065 MEDINA ROAD | MEDINA | OH | 44256 |
| K000797 | ORTHOPAEDIC BIOSYSTEMS, LTD. |
15990 N GREENWAY-HAYDEN LOOP | SCOTTSDALE | AZ | 85260 |
| K982996 | ORTHOPAEDIC BIOSYSTEMS, LTD. |
15990 N GREENWAY-HAYDEN LOOP | SCOTTSDALE | AZ | 85260 |
| K173693 | Orthovestments, LLC |
1640 Powers Ferry Bldg 9 | Marietta | GA | 30067 |
| K141550 | OT MEDICAL |
1000 CONTINENTAL DRIVE, SUITE 240 | KING OF PRUSSIA | PA | 19406 |
| K170923 | Paragon 28 |
4B Inverness Ct. E., STE 280 | Englewood | CO | 80112 |
| K230550 | Paragon 28 Inc |
14445 Grasslands Drive | Englewood | CO | 80112 |
| K223056 | Paragon 28, Inc. |
14445 Grasslands Dr. | Englewood | CO | 80112 |
| K954443 | POLY-MEDICS,INC. |
AIRPORT INDUSTRIAL PARK | WARSAW | IN | 46581-0587 |
| K231458 | restor3d |
311 West Corporation Street | Durham | NC | 27701 |
| K162321 | RESTORE SURGICAL LLC dba Instratek |
15200 Middlebrook Drive, Suite G | Houston | TX | 77058 |
| K071479 | SMALL BONE INNOVATIONS INC. |
505 PARK AVE., 14TH FLOOR | NEW YORK | NY | 10022 |
| K081098 | SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K082215 | SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K020948 | SMITH & NEPHEW, INC. |
160 DASCOMB RD. | ANDOVER | MA | 01810 |
| K023417 | SMITH & NEPHEW, INC. |
160 DASCOMB RD. | ANDOVER | MA | 01810 |
| K124045 | SOLANA SURGICAL, LLC |
6363 POPLAR AVENUE | MEMPHIS | TN | 38119 |
| K122113 | STRYKER CORP. |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K210582 | Stryker GmbH |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K160813 | STRYKER GMBH |
325 CORPORATE DRIVE | MAHWAH | NJ | 07430 |
| K102143 | SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
80 SHELTON TECHNOLOGY CENTER | SHELTON | CT | 06484 |
| K191463 | Synthes (USA) Products, LLC |
1301 Goshen Parkway | West Chester | PA | 19380 |
| K180544 | Synthes (USA) Products, LLC |
1301 Goshen Parkway | West Chester | PA | 19380 |
| K002695 | TELOS MEDICAL EQUIPMENT |
1109 STURBRIDGE RD. | FALLSTON | MD | 21047 |
| K232387 | Treace Medical Concepts |
100 Palmetto Park Place | Ponte Vedra | FL | 32081 |
| K222645 | Treace Medical Concepts |
203 Fort Wade Road, Suite 150 | Ponte Vedra | FL | 32081 |
| K172405 | Trilliant Surgical |
6721 Portwest Drive | Houston | TX | 77024 |
| K162354 | TRILLIANT SURGICAL LTD |
6721 Portwest Dr. Suite 160 | Houston | TX | 77024 |
| K190166 | TriMed, Inc. |
27533 Avenue Hopkins | Santa Clarita | CA | 91355 |
| K221947 | Tyber Medical, LLC. |
83 South Commerce Way | Bethlehem | PA | 18017 |
| K961585 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. | NORWALK | CT | 06856 |
| K961578 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. | NORWALK | CT | 06856 |
| K062734 | VALPO ORTHOPEDIC TECHNOLOGY, INC. |
4805 LAKERIDGE CT. | VALPARAISO | IN | 46383 |
| K112837 | VILEX, INC. |
111 MOFFITT STREET | MCMINNVILLE | TN | 37110 |
| K231493 | Vilex, LLC |
111 Moffitt Street | McMinnville | TN | 37110 |
| K203832 | Wright Medical |
1023 Cherry Road | Memphis | TN | 38117 |
| K043059 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K010051 | XIROS PLC |
28-30 BLENHEIM TERRACE | LEEDS | LS2 9HD |
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