FDA 510(k) Applications for Medical Device:
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K080647 | ACCELERATED INNOVATION, LLC |
1033 US HIGHWAY 46 EAST | CLIFTON | NJ | 07013 |
| K060707 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K080979 | BIOMET MANUFACTURING CORP. |
PO BOX 587 | WARSAW | IN | 46581-0587 |
| K960643 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K003363 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K052990 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K991990 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K082705 | BIOPRO, INC. |
17 SEVENTEENTH ST. | PORT HURON | MI | 48060 |
| K100761 | BIOPRO, INC. |
17 SEVENTEENTH ST. | PORT HURON | MI | 48060 |
| K040947 | CENTERPULSE ORTHOPEDICS, INC. |
9900 SPECTRUM DR. | AUSTIN | TX | 78717 |
| K112019 | CORENTEC CO., LTD |
11TH CHUNGHO TOWER | SEOCHO GU, SEOUL | 137-040 | |
| K183114 | Corin USA Limited |
12750 Citrus Park Lane | Tampa | FL | 33625 |
| K123991 | DEPUY FRANCE S.A.S. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581 |
| K231526 | DePuy Ireland UC |
Loughbeg | Co. Cork | ||
| K014072 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004 |
| K010081 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K013211 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K223441 | G21, S.r.l. |
Via Sandro Petrini, 8 | San Possidonio | 41039 | |
| K191016 | Heraeus Medical GmbH |
Philipp-Reis-Str. 8/13 | Werheim | 61273 | |
| K220492 | Heraeus Medical GmbH |
Philipp-Reis-Str. 8/13 | Wehrheim | 61273 | |
| K191569 | Implantcast, GmbH |
Luneburger Schanze 26 | Buxtehude | 21614 | |
| K132539 | IMPLANTS INTERNATIONAL, LTD |
4170 BOWMANSROOT COURT | HILLIARD | OH | 43026 |
| K970447 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K982812 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K980801 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K945518 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
P.O. BOX 386 | KING OF PRUSSIA | PA | 19406 |
| K963885 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K200709 | Kyocera Medical Technologies, Inc. |
1200 California St Suite 210 | Redlands | CA | 92374 |
| K091967 | MEDACTA INTERNATIONAL, SA |
13721 VIA TRES VISTA | SAN DIEGO | CA | 92129 |
| K082468 | OMNI LIFE SCIENCE, INC. |
175 PARAMOUNT DRIVE | RAYNHAM | MA | 02767 |
| K100151 | OMNLIFE SCIENCE |
175 PARAMOUNT DRIVE | RAYNHAM | MA | 02767 |
| K180130 | Onkos Surgical, Inc. |
77 East Halsey Road | Parsippany | NJ | 07054 |
| K961793 | ORTHO DEVELOPMENT CORP. |
106 WEST 12200 SOUTH | DRAPER | UT | 84020 |
| K982389 | ORTHO DEVELOPMENT CORP. |
106 WEST 12200 SOUTH | DRAPER | UT | 84020 |
| K050966 | ORTHO DEVELOPMENT CORP. |
12187 SOUTH BUSINESS PARK DR. | DRAPER | UT | 84020 |
| K962448 | ORTHO DEVELOPMENT CORP. |
106 WEST 12200 SOUTH | DRAPER | UT | 84020 |
| K953977 | ORTHO DEVELOPMENT CORP. |
106 WEST 12200 SOUTH | DRAPER | UT | 84020 |
| K982447 | PLUS ORTHOPEDICS |
3550 GENERAL ATOMICS CT. | SAN DIEGO | CA | 92121-1122 |
| K131354 | RENOVIS SURGICAL TECHNOLOGIES LLC |
200 HOMER AVE | ASHLAND | MA | 0172-0000 |
| K163081 | SIGNATURE ORTHOPAEDICS PTY LTD. |
7 SIRIUS ROAD | LANE COVE | 2066 | |
| K023743 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K173455 | SurgTech, Inc., |
24600 Center Ridge Road, Suite 195 | Westlake | OH | 44145 |
| K121509 | TGM MEDICAL, INC. |
5145 Golden Foothill Parkway | El Dorado Hills | CA | 95762 |
| K191297 | Theken Companies, LLC |
1800 Triplett Blvd | Akron | OH | 44306 |
| K143113 | Total Joint Orthopedics |
1567 E. Stratford Avenue | Salt Lake City | UT | 84106 |
| K970284 | TURNKEY INTERGRATION USA, INC. |
962 S. TAMIAMI TRAIL SUITE 203 | SARASOTA | FL | 34326 |
| K050269 | UNITED ORTHOPEDIC CORP. |
57 PARK AVE. 2, SCIENCE PARK | HSINCHU | 300 | |
| K101670 | UNITED ORTHOPEDIC CORP. |
NO 57 PARK AVE. 2 | HSINCHU | 300 | |
| K152439 | UNITED ORTHOPEDIC CORPORATION |
NO 57, PARK AVE 2, SCIENCE PARK | HSINCHU | 300 | |
| K221794 | Waldemar Link GmbH & Co. KG |
Oststra▀e 4-10 | Norderstedt | 22844 | |
| K981238 | WHITESIDE BIOMECHANICS, INC. |
12634 OLIVE BLVD. | ST. LOUIS | MO | 63141 |
| K062693 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K192236 | Zimmer GmbH |
Sulzer Allee 8 | Winterthur | 8404 | |
| K170072 | Zimmer GmbH |
Sulzerallee 8 | Winterthur | 8404 |
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