FDA 510(k) Applications for Medical Device:
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K060692 |
BIOMET MANUFACTURING CORP. |
PO BOX 587
| WARSAW |
IN |
46581-0587 |
K193038 |
Biomet Manufacturing Corp. |
56 East Bell Drive
| Warsaw |
IN |
46580 |
K140390 |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE
| WARSAW |
IN |
46581-0587 |
K060716 |
BIOMET MANUFACTURING CORP. |
PO BOX 587
| WARSAW |
IN |
46581-0587 |
K123297 |
BIOMET MANUFACTUTING CORP. |
56 EAST BELL DRIVE
| WARSAW |
IN |
46581 |
K112905 |
BIOMET ORTHOPEDICS LLC. |
P.O. BOX 587
| WARSAW |
IN |
46581-0587 |
K183553 |
Biomet, Inc |
56 East Bell Drive
| Warsaw |
IN |
46581 |
K032895 |
BIOMET, INC. |
56 EAST BELL DR.
| WARSAW |
IN |
46581-0587 |
K043100 |
BIOMET, INC. |
56 EAST BELL DR.
| WARSAW |
IN |
46581-0587 |
K010635 |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK,
| WARSAW |
IN |
46581-0587 |
K130126 |
BIOMET, INC. |
56 EAST BELL DR.
| WARSAW |
IN |
46581-0587 |
K231516 |
Depuy Ireland UC |
Loughbeg
| Ringaskiddy |
|
|
K212933 |
Depuy Ireland UC |
Loughbeg
| Ringaskiddy |
|
|
K011047 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR.
| WARSAW |
IN |
46581-0988 |
K063652 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE
| WARSAW |
IN |
46581-0988 |
K011099 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE
| WARSAW |
IN |
46581-0988 |
K081448 |
ENCORE MEDICAL, L.P. |
9800 METRIC BLVD.
| AUSTIN |
TX |
78758 |
K162068 |
Fournitures Hospitalieres Industrie |
ZI de Kernevez û 6 rue Nobel
| Quimper |
|
29000 |
K202716 |
Ignite Orthopedics LLC |
700 Park Avenue Suite F
| Winona Lake |
IN |
46590 |
K191963 |
LimaCorporate S.p.A |
Via Nazionale 52
| Villanova di San Daniele del Friuli |
|
33038 |
K222427 |
LimaCorporate S.p.A. |
Via Nazionale 52
| Villanova di San Daniele del Friuli |
|
33038 |
K201905 |
LimaCorporate S.p.A. |
Via Nazionale 52
| Villanova di San Daniele del Friuli |
|
33038 |
K163397 |
Limacorporate S.p.A. |
via Nazionale 52
| Villanova di San Daniele |
|
33038 |
K220792 |
LimaCorporate S.p.A. |
Via Nazionale 52
| Villanova di San Daniele del Friuli |
|
33038 |
K223876 |
LimaCorporate S.p.A. |
Via Nazionale 52
| Villanova di San Daniele del Friuli |
|
33038 |
K173824 |
Shoulder Innovations Inc |
13827 Port Sheldon Street
| Holland |
MI |
49424 |
K070565 |
SMITH & NEPHEW, INC. |
1450 E BROOKS RD
| MEMPHIS |
TN |
38116 |
K083439 |
SYNTHES (USA) |
1301 GOSHEN PKWY.
| WEST CHESTER |
PA |
19380 |
K213856 |
Zimmer Inc. |
P.O Box 708
| Warsaw |
IN |
46581-0708 |
|
|