FDA 510(k) Applications for Medical Device:
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K101815 | AESCULAP IMPLANT SYSTEMS |
3773 CORPORATE PWKY. | CENTER VALLEY | PA | 18034 |
| K083779 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46581-0587 |
| K083827 | BIOMET MANUFACTURING CORP. |
PO BOX 587 | WARSAW | IN | 46581-0587 |
| K060131 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46581-0587 |
| K140509 | BIOMET MANUFACTURING LLC |
56 EAST BELL DR. | WARSAW | IN | 46581 |
| K051479 | BIOMET MANUFACTURING, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K131393 | BIOMET ORTHOPEDICS CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46582 |
| K020381 | BIOMET ORTHOPEDICS, INC. |
P.O. BOX 587 | WARSAW | IN | 46581-0587 |
| K010774 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K051570 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K031804 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K041352 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K945028 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K052685 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K021260 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K080330 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K191779 | Depuy (Ireland) |
Loughbeg Ringaskiddy | Co. Cork Munster | ||
| K233980 | DePuy Ireland UC |
Loughbeg | Ringaskiddy | ||
| K242871 | DePuy Ireland UC |
Loughbeg | Ringaskiddy | ||
| K062301 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR. | WARSAW | IN | 46581-0988 |
| K091453 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K011810 | DEPUY, INC. |
700 ORTHOPAEDIC DR. | WARSAW | IN | 46581-0988 |
| K982160 | ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K972401 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K060360 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K040749 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K122015 | HOWMEDICA OSTEONICS CORP. |
325 CORPORATE DR | MAHWAH | NJ | 07430 |
| K023087 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K031480 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401 |
| K002552 | HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070-2584 |
| K994207 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K001548 | HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070-2584 |
| K001957 | HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070-2584 |
| K223069 | Howmedica Osteonics Corp. dba Stryker Orthopaedics |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K223528 | Howmedica Osteonics Corp. dba Stryker Orthopaedics |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K251665 | Howmedica Osteonics Corp. dba Stryker Orthopaedics |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K190181 | Link Bio Corp. |
101 Roundhill Drive | Rockaway | NJ | 07866 |
| K130299 | MEDACTA INTERNATIONAL |
4725 Calle Quetzal, Unit B | Camarillo | CA | 93012 |
| K172347 | Medacta International SA |
Strada Regina | Castel San Pietro | CH-6874 | |
| K210010 | Medacta International SA |
Strada Regina | Castel San Pietro | CH-6874 | |
| K163311 | Medacta International SA |
Strada Regina | Castel San Pietro | CH-6874 | |
| K230563 | MicroPort Orthopedics Inc. |
5677 Airline Road | Arlington | TN | 38002 |
| K240043 | MicroPort Orthopedics Inc. |
5677 Airline Road | Arlington | TN | 38002 |
| K211677 | Onkos Surgical |
77 East Halsey Rd | Parsippany | NJ | 07054 |
| K161520 | Onkos Surgical, Inc. |
77 East Halsey Road | Parsippany | NJ | 07054 |
| K013340 | PLUS ORTHOPEDICS |
6055 LUSK BLVD. | SAN DIEGO | CA | 92121-2700 |
| K003504 | PLUS ORTHOPEDICS |
3550 GENERAL ATOMICS CT. | SAN DIEGO | CA | 92121-1194 |
| K021714 | PLUS ORTHOPEDICS |
6055 LUSK BLVD. | SAN DIEGO | CA | 92121-2700 |
| K023667 | PLUS ORTHOPEDICS |
1001 OAKWOOD BLVD. | ROUND ROCK | TX | 78681-2700 |
| K151118 | SMITH & NEPHEW |
7135 GOODLETT FARMS PARKWAY | CORDOVA | TN | 38016 |
| K081111 | SMITH & NEPHEW, INC. |
1450 E BROOKS ROAD | MEMPHIS | TN | 38116 |
| K121029 | STANMORE IMPLANTS WORLDWIDE LTD |
690 CANTON STREET | WESTWOOD | MA | 02090 |
| K120992 | STANMORE IMPLANTS WORLDWIDE LTD |
690 CANTON STREET | WESTWOOD | MA | 02090 |
| K092138 | STANMORE IMPLANTS WORLDWIDE LTD. |
555 THIRTEENTH ST, NW | WASHINGTON | DC | 20004 |
| K133152 | STANMORE IMPLANTS WORLDWIDE LTD. |
555 THIRTEENTH ST, NW | WASHINGTON | DC | 20004 |
| K140898 | STANMORE IMPLANTS WORLDWIDE LTD. |
10 CORDAGE ROAD PARK CIRCLE, SUITE 200 | PLYMOUTH | MA | 02360 |
| K140900 | Stanmore Worldwide Implants Ltd. |
10 CORDAGE ROAD PARK CIRCLE, SUITE 200 | PLYMOUTH | MA | 02360 |
| K230416 | Stryker |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K013031 | SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. | AUSTIN | TX | 78717 |
| K190100 | United Orthopedic Corporation |
No 57, Park Ave 2, Science Park | Hsinchu | 30075 | |
| K220628 | Waldemar Link GmbH & Co. KG |
Oststra▀e 4-10 | Norderstedt | 22844 | |
| K152431 | WALDEMAR LINK GMBH & CO. KG |
BARKHAUSENWEG 10 | HAMBURG | 22339 | |
| K211768 | Waldemar Link GmbH & Co. KG |
Oststra▀e 4-10 | Norderstedt | 22844 | |
| K151008 | Waldemar Link GmbH & Co. KG |
Barkhausenweg 10 | Hamburg | 22339 | |
| K143179 | Waldemar Link GmbH & Co. KG |
Barkhausenweg 10 | Hamburg | 22339 | |
| K013035 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K072367 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K021489 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K013385 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K110940 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K192798 | Zimmer, Inc. |
1800 W. Center Street | Warsaw | IN | 46580 |
| K070978 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
| K150028 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
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