FDA 510(k) Applications for Medical Device:
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K230513 | Arthrex Inc |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K181555 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K171841 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K182799 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K210050 | Arthrex Inc. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K010124 | ARTHREX, INC. |
2885 SOUTH HORSESHOE DR. | NAPLES | FL | 34104 |
| K131633 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K153115 | ARTHREX, INC. |
1370 CREEKSIDE BOULEVARD | NAPLES | FL | 34108-1945 |
| K020345 | ARTHREX, INC. |
2885 SOUTH HORSESHOE DR. | NAPLES | FL | 34104 |
| K083435 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K071032 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K103466 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K120044 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K161108 | ARTHREX, INC. |
1370 Creekside Boulevard | Naples | FL | 34108-1945 |
| K130129 | ARTHREX, INC. |
1370 Creekside Blvd | Naples | FL | 34108 |
| K091196 | ARTHROSURFACE, INC. |
28 FORGE PARKWAY | FRANKLIN | MA | 02038 |
| K112438 | ASCENSION ORTHOPEDIC |
8700 CAMERON RD., STE. 100 | Austin | TX | 78754 |
| K130050 | ASCENSION ORTHOPEDIC |
8700 CAMERON RD., STE. 100 | Austin | TX | 78754 |
| K152047 | ASCENSION ORTHOPEDICS |
8700 CAMERON ROAD, SUITE 100 | AUSTIN | TX | 78754 |
| K142413 | Ascension Orthopedics |
8700 Cameron Road | Austin | TX | 78754 |
| K100448 | ASCENSION ORTHOPEDICS, INC. |
8700 CAMERON RD., STE. 100 | AUSTIN | TX | 78754-3832 |
| K133462 | ASTON MEDICAL |
577 North Hope Ave | Santa Barbara | CA | 93110 |
| K212435 | Biomet Inc. |
56 East Bell Drive | Warsaw | IN | 46581 |
| K060694 | BIOMET MANUFACTURING CORP. |
PO BOX 587 | WARSAW | IN | 46581-0587 |
| K040610 | BIOMET MANUFACTURING, INC. |
P.O. BOX 587 | WARSAW | IN | 46581-0578 |
| K992899 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K992119 | BIOMET, INC. |
P.O. BOX 587 | WARSAW | IN | 46581-0587 |
| K033506 | BIOMET, INC. |
P.O. BOX 587 | WARSAW | IN | 46581-0587 |
| K001046 | BIOPRO, INC. |
17 SEVENTEENTH ST. | PORT HURON | MI | 48060 |
| K222317 | Catalyst OrthoScience, Inc. |
14710 Tamiami Trail North | Naples | FL | 34110 |
| K030259 | CENTERPLUS ORTHOPEDICS, INC |
9900 SPECTRUM DR. | AUSTIN | TX | 78717 |
| K123122 | CLEVELAND CLINIC |
10000 CEDAR AVENUE | CLEVELAND | OH | 44106 |
| K151500 | CUSTOM ORTHOPAEDIC SOLUTIONS |
10000 CEDAR AVE | CLEVELAND | OH | 44106 |
| K162697 | Custom Orthopaedic Solutions, Inc. |
7100 Euclid Ave., Ste. 180 | Cleveland | OH | 44103 |
| K142072 | CUSTOM ORTHOPAEDIC SOLUTIONS, INC. |
10000 CEDAR AVENUE | CLEVELAND | OH | 44106 |
| K153215 | Custom Orthopaedic Solutions, Inc. |
10000 Cedar Avenue | Cleveland | OH | 44106 |
| K133834 | DEPUY (IRELAND) |
LOUGHBEG RINGASKIDDY | CO. CORK | IRELAND | |
| K203230 | DePuy lnc. |
700 Orthopaedic Drive | Warsaw | IN | 46581-0988 |
| K091751 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K060874 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR. | WARSAW | IN | 46581-0988 |
| K052472 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K981487 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K000575 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K992065 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K092122 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K974044 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K081620 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K060988 | DVO EXTREMITY SOLUTIONS, LLC |
P.O. BOX 205 | DERBY | CT | 06418 |
| K162024 | ENCORE MEDICAL, L.P |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K222592 | Encore Medical, L.P |
9800 Metric Blvd | Austin | TX | 78758 |
| K190290 | Encore Medical, L.P. |
9800 Metric Blvd. | Austin | TX | 78758 |
| K172351 | Encore Medical, L.P. |
9800 Metric Blvd | Austin | TX | 78758 |
| K203026 | Encore Medical, L.P. |
9800 Metric Blvd. | Austin | TX | 78758 |
| K213387 | Encore Medical, L.P. |
9800 Metric Boulevard | Austin | TX | 78758 |
| K080402 | ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K130048 | ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K123982 | ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K960906 | ENCORE ORTHOPEDICS, INC. |
8900 SHOAL CREEK BLVD., | AUSTIN | TX | 78757 |
| K003324 | ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K140063 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K121220 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K111379 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K113309 | EXACTECH, INC. |
2320 NW 66TH COURT | GAINESVILLE | FL | 32605 |
| K103419 | EXACTECH, INC. |
2320 N.W. 66TH COURT | GAINESVILLE | FL | 32653 |
| K042021 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K093430 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K212356 | Exactech, Inc. |
2320 NW 66th Ct. | Gainesville | FL | 32653 |
| K093599 | FOURNITURES HOSPITALIERES INDUSTRIE |
ZI DE KERNEVEZ-6 RUE NOBEL | QUIMPER | 29000 | |
| K043346 | GENESIS MEDICAL L.L.C. |
2650 US HIGHWAY 130 | CRANBURY | NJ | 08512 |
| K103835 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K103104 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K990598 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K062113 | HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K031449 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K131277 | INGEN ORTHOPEDICS LLC |
2650 US HIGHWAY 130 | CRANBURY | NJ | 08512 |
| K962224 | INTERMEDICS ORTHOPEDICS |
9900 SPECTRUM DR. | AUSTIN | TX | 78717 |
| K213785 | LimaCorporate |
Via Nazionale, 52 | Villanova di San Daniele del Friuli | 33038 | |
| K131112 | LIMACORPORATE S.P.A. |
P.O. BOX 696 | WINONA LAKE | IN | 46590-696 |
| K130642 | LIMACORPORATE S.P.A. |
P.O. BOX 696 | WINONA LAKE | IN | 46590-696 |
| K153722 | Limacorporate S.p.A. |
via Nazionale, 52 | Villanova di San Daniele | 33038 | |
| K183042 | Limacorporate S.p.A. |
Via Nazionale 52 | Villanova di San Daniele | 33038 | |
| K143256 | Limacorporate S.P.A. |
Via Nazionale, 52 | Villanova di San Daniele | 33038 | |
| K110847 | LIMACORPORATE S.P.A. |
P.O. BOX 696 | WINONA LAKE | IN | 46590-696 |
| K111212 | LIMACORPORATE S.P.A. |
P.O. BOX 696 | WINONA LAKE | IN | 46590-696 |
| K133349 | LIMACORPORATE S.P.A. |
5010 LODGE POLE LANE | FORT WAYNE | IN | 46814 |
| K131559 | MATERIALISE N.V. |
TECHNOLOGIELAAN 15 | LEUVEN | 3001 | |
| K153602 | MATERIALISE NV |
TECHNOLOGIELAAN 15 | LEUVEN | 3001 | |
| K170893 | Materialise NV |
Technologielaan 15 | Leuven | 3001 | |
| K172054 | Materialise NV |
Technologielaan 15 | Leuven | 3001 | |
| K190286 | Materialise NV |
Technologielaan 15 | Leuven | 3001 | |
| K170910 | Medacta International SA |
Strada Regina | Castel San Pietro | CH-6874 | |
| K962082 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K955944 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K955731 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K152267 | Osteoremedies LLC |
6800 Poplar Avenue Suite 120 | Memphis | TN | 38138 |
| K111596 | SHOULDER INNOVATIONS, LLC |
4670 FULTON STREET E | ADA | MI | 49301 |
| K102670 | SHOULDER INNOVATIONS, LLC |
4670 FULTON STREET EAST | ADA | MI | 49301 |
| K110905 | SHOULDER INNOVATIONS, LLC |
4670 FULTON STREET EAST | ADA | MI | 49301 |
| K955767 | SMITH & NEPHEW RICHARDS, INC. |
1450 E. BROOKS RD. | MEMPHIS | TN | 38116 |
| K012378 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K220847 | Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K230572 | Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K003566 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K030344 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K994350 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K113012 | SMITH & NEPHEW, INC. |
1450 BROOKS ROAD | MEMPHIS | TN | 38116 |
| K213827 | Smith & Nephew, Inc. |
11101 Metric Blvd | Austin | TX | 78758 |
| K012788 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K161863 | Stryker GmbH |
Bohnackerweg 1 | 2545 Selzach | CH 2545 | |
| K181742 | Stryker GmbH |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K183039 | Stryker GmbH |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K202289 | Stryker GmbH |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K210861 | Stryker GmbH |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K172210 | Stryker Trauma AG |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K990136 | SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. | AUSTIN | TX | 78717 |
| K990137 | SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. | AUSTIN | TX | 78717 |
| K003801 | SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. | AUSTIN | TX | 78717 |
| K971715 | SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. | AUSTIN | TX | 78717 |
| K003832 | SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. | AUSTIN | TX | 78717 |
| K191247 | TechMah Medical LLC |
2099 Thunderhead Rd., Suite 302 | Knoxville | TN | 37922 |
| K082120 | TORNIER |
161 RUE LAVOISIER | SAINT-ISMIER CEDEX | 38334 | |
| K994392 | TORNIER |
200 GREGORY LN. | PLEASANT HILL | CA | 94523-3389 |
| K032679 | TORNIER |
ZIRST-161, RUE LAVOISIER | MONTBONNOT | 38330 | |
| K060209 | TORNIER |
161 RUE LAVOISIER | SAINT-ISMIER CEDEX | 38334 | |
| K980244 | TORNIER |
1000 BURNETT AVE. | CONCORD | CA | 94520 |
| K111902 | TORNIER |
161 RUE LAVOISIER | MONTBONNOT, SAINT-ISMIER | 38334 | |
| K041339 | TORNIER |
ZIRST-161, RUE LAVOISIER | MONTBONNOT | 38330 | |
| K994393 | TORNIER |
200 GREGORY LN. | PLEASANT HILL | CA | 94523-3389 |
| K003728 | TORNIER |
200 GREGORY LN. | PLEASANT HILL | CA | 94523-3389 |
| K043077 | TORNIER |
161 RUE LAVOISIER | MONTBONNOT, SAINT-ISMIER | 38334 | |
| K012212 | TORNIER |
ZIRST-161, RUE LAVOISIER | MONTBONNOT | 38330 | |
| K122698 | Tornier SAS |
10801 Nesbitt Avenue South | Bloomington | MN | 55437 |
| K190521 | Tornier SAS |
161 Rue Lavoisier | Monbonnot Saint Martin | 38330 | |
| K151293 | Tornier SAS |
161 Rue Lavoisier | Monbonnot Saint Martin | 38334 | |
| K160555 | TORNIER SAS |
161 RUE LAVOISIER | MONTBONNOT SAINT MARTIN | 38330 | |
| K162800 | TORNIER SAS |
161 rue LAVOISIER | MONTBONNOT SAINT MARTIN | 38330 | |
| K161789 | TORNIER SAS |
161 RUE LAVOISIER | MONTBONNOT SAINT-MARTIN | 38330 | |
| K203315 | Tornier SAS |
161 rue Lavoisier | Montbonnot Saint Martin | 38330 | |
| K102924 | TORNIER, INC. |
100 CUMMINGS CENTER | BEVERLY | MA | 01915 |
| K110865 | TORNIER, INC. |
100 CUMMINGS CENTER, | BEVERLY | MA | 01915 |
| K181420 | Tornier, Inc. |
10801 Nesbitt Ave South | Bloomington | MN | 55437 |
| K191318 | Tornier, Inc. |
10801 Nesbitt Avenue South | Bloomington | MN | 55340 |
| K150583 | TORNIER, INC. |
10801 NESBITT AVENUE SOUTH | BLOOMINGTON | MN | 55437 |
| K160975 | TORNIER, INC. |
10801 Nesbitt Avenue South | Bloomington | MN | 55437 |
| K081707 | TORNIER, INC. |
100 CAPITAL DRIVE | WARSAW | IN | 46582 |
| K103007 | TORNIER, INC. |
100 CUMMINGS CENTER | BEVERLY | MA | 01915 |
| K113413 | TORNIER, INC. |
7701 FRANCE AVE SOUTH | EDINA | MN | 55435 |
| K120794 | TORNIER, INC. |
7701 FRANCE AVE SOUTH | EDINA | MN | 55435 |
| K121493 | TORNIER, INC. |
7701 FRANCE AVE SOUTH | EDINA | MN | 55435 |
| K143374 | TORNIER, SAS |
161 RUE LAVOISIER | MONTBONNOT SAINT MARTIN | 38330 | |
| K001706 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K002683 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K131129 | ZIMMER CAS |
1800 WEST CENTER STREET | WARSAW | IN | 46580 |
| K062029 | ZIMMER GMBH |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K051623 | ZIMMER GMBH |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K160085 | ZIMMER GMBH |
SULZERALLEE 8 | WINTERTHUR | 8404 | |
| K142403 | ZIMMER GMBH |
SULZERALLEE 8 | WINTERTHUR | 8404 | |
| K193180 | Zimmer Inc. |
P.O. Box 708 | Warsaw | IN | 46581-0708 |
| K191814 | Zimmer Inc. |
P.O. Box 708 | Warsaw | IN | 46581-0708 |
| K043061 | ZIMMER TRABECULAR |
80 COMMERCE DR. | ALLENDALE | NJ | 07401 |
| K071090 | ZIMMER TRABECULAR METAL TECHNOLOGY |
10 POMEROY RD. | PARSIPPANY | NJ | 07054 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
