FDA 510(k) Applications for Medical Device:
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K043079 | AESCULAP |
3773 CORPORATE PKWY. | CENTER VALLEY | PA | 18034 |
| K080584 | AESCULAP IMPLANT SYSTEM, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K092143 | AESCULAP IMPLANT SYSTEMS, INC. |
3773 CORPORATE PWKY. | CENTER VALLEY | PA | 18034 |
| K071916 | AESCULAP IMPLANT SYSTEMS, INC. |
3773 CORPORATE PKWY. | CENTER VALLEY | PA | 18034 |
| K102424 | AESCULAP IMPLANT SYSTEMS, LLC |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K060437 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K000262 | BIOMET MANUFACTURING, INC. |
AIRPORT INDUSTRIAL PARK | WARSAW | IN | 46581-0587 |
| K021403 | BIOMET ORTHOPEDICS, INC. |
P.O. BOX 587 | WARSAW | IN | 46581-0587 |
| K020963 | BIOMET ORTHOPEDICS, INC. |
P.O. BOX 587 | WARSAW | IN | 46581-0587 |
| K001580 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K231178 | Conformis Inc |
600 Technology Park Dr | Billerica | MA | 01821 |
| K221104 | Conformis Inc. |
600 Technology Park Drive, 4th Floor | Billerica | MA | 01821 |
| K093472 | CORIN U.S.A. |
10500 UNIVERSITY CENTER DR., | TAMPA | FL | 33612 |
| K121563 | CORIN USA |
10500 UNIVERSITY CENTER DRIVE | TAMPA | FL | 33612 |
| K173880 | Corin USA Limited |
12750 Citrus Park Lane | Tampa | FL | 33625 |
| K153772 | CORIN USA LIMITED |
5670 W. CYPRESS ST. | TAMPA | FL | 33607 |
| K241472 | Corin USA Limited |
12750 Citrus Park Lane | Tampa | FL | 33625 |
| K160907 | DEPUY (IRELAND) |
LOUGHBEG RINGASKIDDY | Co. Cork | ||
| K210581 | DePuy Ireland UC |
Loughbeg | Ringaskiddy | ||
| K231873 | DePuy Ireland UC |
3 Main Street | Ringaskiddy | ||
| K150862 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46582 |
| K193398 | DePuy Orthopaedics, Inc. |
700 Orthopaedic Drive | Warsaw | IN | 46582 |
| K993943 | ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K162732 | EXACTECH INC |
2320 NW 66TH COURT | GAINESVILLE | FL | 32653 |
| K153649 | EXACTECH INC |
2320 NW 66TH COURT | GAINESVILLE | FL | 32653 |
| K000242 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K243839 | Exactech, Inc. |
2320 NW 66th Ct. | Gainesville | FL | 32653 |
| K040613 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K080980 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K990197 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K113320 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K961388 | FOURNITURES HOSPITALIERES |
1700 ROCKVILLE PIKE | ROCKVILLE | MD | 20852 |
| K021108 | FOURNITURES HOSPITALIERES |
C/O PHARMANET, INC. | WASHINGTON | DC | 20006 |
| K964878 | FOURNITURES HOSPITALIERES |
1700 ROCKVILLE PIKE | ROCKVILLE | MD | 20852 |
| K102172 | GLOBAL MANUFACTURING TECHNOLOGY |
1331 H STREET NW | WASHINGTON | DC | 20005 |
| K113107 | GLOBAL MANUFACTURING TECHNOLOGY |
1331 H STREET NW | WASHINGTON | DC | 20005 |
| K955305 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K112556 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K122853 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K081044 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K092561 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K082892 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K091161 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K072020 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K092406 | HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K020572 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K023102 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K032300 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K993768 | HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070-2584 |
| K993077 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K992025 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K093644 | HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K020615 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K994366 | HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070-2584 |
| K001448 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K013676 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K181778 | implantcast GmbH |
Lueneburger Schanze 26 | Buxtehude | 21614 | |
| K200045 | implantcast, GmbH |
Luneburger Schanze 26 | 21614 | ||
| K071583 | IMPLANTS INTERNATIONAL, LTD |
71 JAY AVE.TEESIDE INDSTRL.EST | UNITED KINGDOM | T517-9LZ | |
| K954800 | INTERMEDICS ORTHOPEDICS |
9900 SPECTRUM DR. | AUSTIN | TX | 78717 |
| K041353 | JRI MANUFACTURING LTD |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K961732 | LANDOS, INC. |
9109 COPENHAVER DR. | POTOMAC | MD | 20854 |
| K150855 | Limacorporate S.P.A. |
Via Nazionale, 52 | Villanova di San Daniele | 33038 | |
| K112091 | LIMACORPORATE S.P.A. |
P.O. BOX 696 | WINONA LAKE | IN | 46590-696 |
| K160011 | LIMACORPORATE S.P.A. |
VIA NAZIONALE 52 | VILLANOVA DI SAN DANIELE | 33038 | |
| K251166 | Medacta International S.A. |
Strada Regina | Castel San Pietro | 6874 | |
| K083116 | MEDACTA INTERNATIONAL, SA |
13721 VIA TRES VISTA | SAN DIEGO | CA | 92129 |
| K092265 | MEDACTA INTERNATIONAL, SA |
13721 VIA TRES VISTA | SAN DIEGO | CA | 92129 |
| K241875 | NextStep Arthropedix |
1800 Triplett Blvd | Akron | OH | 44306 |
| K251052 | Ortho Development Corp. |
12187 S. Business Park Drive | Draper | UT | 84020 |
| K233758 | Ortho Development Corp. |
12187 S. Business Park Drive | Draper | UT | 84020 |
| K171249 | Ortho Development Corporation |
12187 South Business Park Drive | Draper | UT | 84020 |
| K971422 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K980766 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K983382 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K980070 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K963959 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K970394 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K982032 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K990203 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K983870 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K951517 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K032641 | PORTLAND ORTHOPAEDICS PTY. LTD. |
3/44 MCCAULEY ST. | MATRAVILLE NSW | 2036 | |
| K992815 | PORTLAND ORTHOPAEDICS PTY. LTD. |
SUITE 3 LEVEL 5 ST. GEORGE | KOGARAH, NEW SOUTH WALES | NSW 2217 | |
| K241690 | Signature Orthopaedics Pty Ltd |
7 Sirius Road | Lane Cove | 2066 | |
| K243162 | Signature Orthopaedics Pty Ltd |
7 Sirius Road | Lane Cove West | 2066 | |
| K211505 | Signature Orthopaedics Pty Ltd. |
7 Sirius Road | Lane Cove | 2066 | |
| K153131 | SIGNATURE ORTHOPAEDICS PTY LTD. |
7 SIRIUS ROAD | LANE COVE | 2066 | |
| K161155 | SIGNATURE ORTHOPAEDICS PTY LTD. |
7 SIRIUS ROAD | LANE COVE | 2066 | |
| K211742 | Signature Orthopaedics Pty Ltd. |
7 Sirius Road | Lane Cove | 2066 | |
| K220495 | Signature Orthopaedics Pty Ltd. |
7 Sirius Road | Lane Cove | 2066 | |
| K201278 | Signature Orthopaedics Pty Ltd. |
7 Sirius Road | Lane Cove | 2066 | |
| K162303 | SMITH & NEPHEW INC. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K040680 | SMITH & NEPHEW, INC. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K023302 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K990666 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K081124 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K113789 | SMITH & NEPHEW, INC. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K090982 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K100481 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K042127 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K052426 | SMITH & NEPHEW, INC. |
1450 E BROOKS ROAD | MEMPHIS | TN | 38116 |
| K113039 | SMITH & NEPHEW, INC. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K121627 | SMITH & NEPHEW, INC. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K002996 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K970337 | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
1450 E. BROOKS RD. | MEMPHIS | TN | 38116 |
| K220731 | Stryker |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K103479 | STRYKER CORP |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K211703 | Stryker Orthopaedics |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K053528 | STRYKER ORTHOPAEDICS |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K971523 | SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. | AUSTIN | TX | 78717 |
| K103497 | UNITED ORTHOPEDIC CORP. |
57 PARK AVE. 2, SCIENCE PARK | HSINCHU | 300 | |
| K242315 | United Orthopedic Corporation |
No 57, Park Ave 2, Science Park | Hsinchu | 30075 | |
| K171273 | Waldemar Link Gmbh & Co. KG |
Barkhausenweg 10 | Hamburg | 22339 |
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