FDA 510(k) Applications for Medical Device:
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K081293 |
AESCULAP IMPLANT SYSTEMS, INC. |
3773 CORPORATE PKWY.
| CENTER VALLEY |
PA |
18034 |
K131167 |
AESCULAP IMPLANT SYSTEMS, LLC |
3773 Corporate Parkway
| Center Valley |
PA |
18034 |
K060412 |
AUSTRALIAN SURGICAL DESIGN & MANUFACTURE |
2530 RIVA ROAD, SUITE 308
| ANNAPOLIS |
MD |
21401 |
K122277 |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE
| WARSAW |
IN |
46581-0587 |
K061681 |
BIOMET MANUFACTURING CORP. |
PO BOX 587
| WARSAW |
IN |
46581-0587 |
K053299 |
BIOMET MANUFACTURING, INC. |
56 EAST BELL DR.
| WARSAW |
IN |
46581-0587 |
K063515 |
BIOMET MANUFACTURING, INC. |
56 EAST BELL DR.
| WARSAW |
IN |
46581-0587 |
K020264 |
BIOMET ORTHOPEDICS, INC. |
P.O. BOX 587
| WARSAW |
IN |
46581-0587 |
K133940 |
BIOMET UK LTD. |
56 EAST BELL DRIVE
| WARSAW |
IN |
46581 |
K011509 |
BIOMET, INC. |
56 EAST BELL DR.
| WARSAW |
IN |
46581-0587 |
K021621 |
BIOMET, INC. |
P.O. BOX 587
| WARSAW |
IN |
46581-0587 |
K011138 |
BIOMET, INC. |
P.O. BOX 587
| WARSAW |
IN |
46581-0587 |
K971938 |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK,
| WARSAW |
IN |
46581-0587 |
K980665 |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK,
| WARSAW |
IN |
46581-0587 |
K030446 |
BIOMET, INC. |
56 EAST BELL DR.
| WARSAW |
IN |
46581-0587 |
K042093 |
BIOMET, INC. |
56 EAST BELL DR.
| WARSAW |
IN |
46581-0587 |
K011795 |
BIOMET, INC. |
56 EAST BELL DR.
| WARSAW |
IN |
46581-0587 |
K033810 |
CENTERPULSE ORTHOPEDICS, INC. |
9900 SPECTRUM DR.
| AUSTIN |
TX |
78717 |
K050764 |
CORIN U.S.A. |
10500 UNIVERSITY CENTER DR.,
| TAMPA |
FL |
33612 |
K193549 |
DePuy Ireland UC |
Loughbeg
| Ringaskiddy |
|
|
K000172 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE
| WARSAW |
IN |
46581-0988 |
K070267 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR.
| WARSAW |
IN |
46582 |
K010810 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR.
| WARSAW |
IN |
46581-0988 |
K040268 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE
| WARSAW |
IN |
46581-0988 |
K001451 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE
| WARSAW |
IN |
46581-0988 |
K022437 |
ENCORE MEDICAL, L.P. |
9800 METRIC BLVD.
| AUSTIN |
TX |
78758 |
K020741 |
ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD.
| AUSTIN |
TX |
78758 |
K040889 |
EXACTECH, INC. |
2320 N.W. 66TH CT.
| GAINESVILLE |
FL |
32653 |
K033351 |
GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. |
5349 RED LEAF COURT
| OVIEDO |
FL |
32765 |
K051721 |
GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. |
5349 RED LEAF COURT
| OVIEDO |
FL |
32765-5018 |
K082567 |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR.
| MAHWAH |
NJ |
07430 |
K071881 |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR.
| MAHWAH |
NJ |
07430 |
K955778 |
INTERMEDICS ORTHOPEDICS |
9900 SPECTRUM DR.
| AUSTIN |
TX |
78717 |
K954481 |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
ROUTE 202 N.
| RARITAN |
NJ |
08869 |
K150410 |
MAKO SURGICAL CORPORATION |
2555 DAVIE ROAD
| FORT LAUDERDALE |
FL |
33317 |
K110415 |
MATERIALISE N.V. |
15 TECHNOLOGIELAAN
| LEUVEN |
|
3001 |
K152631 |
MICROPORT ORTHOPEDICS, INC. |
5677 AIRLINE ROAD
| ARLINGTON |
TN |
38002 |
K190633 |
NanoOrtho, LLC |
860 Oak Park Blvd STE 301
| Arroyo Grande |
CA |
93420 |
K012762 |
OSTEOIMPLANT TECHNOLOGY, INC. |
11201 PEPPER RD.
| HUNT VALLEY |
MD |
21031-1201 |
K983657 |
OSTEONICS CORP. |
59 ROUTE 17
| ALLENDALE |
NJ |
07401-1677 |
K974434 |
OSTEONICS CORP. |
59 ROUTE 17
| ALLENDALE |
NJ |
07401-1677 |
K032052 |
PLUS ORTHOPEDICS |
1001 OAKWOOD BLVD.
| ROUND ROCK |
TX |
78681-2700 |
K982859 |
PLUS ORTHOPEDICS |
3550 GENERAL ATOMICS CT.
| SAN DIEGO |
CA |
92121-1122 |
K072704 |
VALPO ORTHOPEDIC TECHNOLOGY, INC. |
438 E 200 N
| WARSAW |
IN |
46582 |
K012800 |
WHITESIDE BIOMECHANICS, INC. |
12634 OLIVE BLVD.
| ST. LOUIS |
MO |
63141 |
K030193 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD.
| ARLINGTON |
TN |
38002 |
K960617 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD.
| ARLINGTON |
TN |
38002 |
K012591 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD.
| ARLINGTON |
TN |
38002 |
K014171 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD.
| ARLINGTON |
TN |
38002 |
K100973 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD.
| ARLINGTON |
TN |
38002 |
K961900 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD.
| ARLINGTON |
TN |
38002 |
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