FDA 510(k) Applications for Medical Device:
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K021661 |
BIOMET ORTHOPEDICS, INC. |
P.O. BOX 587
| WARSAW |
IN |
46581-0587 |
K030047 |
BIOMET, INC. |
56 EAST BELL DR.
| WARSAW |
IN |
46581-0587 |
K021728 |
BIOMET, INC. |
56 EAST BELL DR.
| WARSAW |
IN |
46581-0587 |
K030923 |
CENTERPULSE ORTHOPEDICS, INC. |
9900 SPECTRUM DR.
| AUSTIN |
TX |
78717 |
K071059 |
DEPUY ORTHOPAEDICS, INC. |
P.O. BOX 988
| WARSAW |
IN |
46581-0988 |
K071117 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR.
| WARSAW |
IN |
46582 |
K052079 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE
| WARSAW |
IN |
46581-0988 |
K043058 |
DEPUY, INC. |
700 ORTHOPAEDIC DR.
| WARSAW |
IN |
46582 |
K023794 |
ENCORE MEDICAL, L.P. |
9800 METRIC BLVD.
| AUSTIN |
TX |
78758 |
K161610 |
Encore Medical, L.P. |
9800 METIRC BLVD
| AUSTIN |
TX |
78758 |
K163497 |
ENCORE MEDICAL, L.P. |
9800 METRIC BLVD.
| Austin |
TX |
78758 |
K040601 |
EXACTECH, INC. |
2320 N.W. 66TH CT.
| GAINESVILLE |
FL |
32653 |
K071676 |
EXACTECH, INC. |
2320 N.W. 66TH CT.
| GAINESVILLE |
FL |
32653 |
K063445 |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR.
| MAHWAH |
NJ |
07430 |
K063552 |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR.
| MAHWAH |
NJ |
07430 |
K063550 |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR.
| MAHWAH |
NJ |
07430 |
K061654 |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR.
| MAHWAH |
NJ |
07430 |
K040225 |
OSTEOIMPLANT TECHNOLOGY, INC. |
11201 PEPPER RD.
| HUNT VALLEY |
MD |
21031-1201 |
K083566 |
SMITH & NEPHEW, INC. |
1450 BROOKS RD.
| MEMPHIS |
TN |
38116 |
K021803 |
SMITH & NEPHEW, INC. |
1450 BROOKS RD.
| MEMPHIS |
TN |
38116 |
K033442 |
SMITH & NEPHEW, INC. |
1450 BROOKS RD.
| MEMPHIS |
TN |
38116 |
K122139 |
SMITH & NEPHEW, INC. |
1450 BROOKS RD.
| MEMPHIS |
TN |
38116 |
K111635 |
SMITH & NEPHEW, INC. |
1450 BROOKS RD.
| MEMPHIS |
TN |
38116 |
K162641 |
Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway
| Cordova |
TN |
38016 |
K101730 |
ZIMMER, INC. |
P.O. BOX 708
| WARSAW |
IN |
46581-0708 |
K072121 |
ZIMMER, INC. |
P.O. BOX 708
| WARSAW |
IN |
46581-0708 |
K021826 |
ZIMMER, INC. |
P.O. BOX 708
| WARSAW |
IN |
46581-0708 |
K071718 |
ZIMMER, INC. |
P.O. BOX 708
| WARSAW |
IN |
46581-0708 |
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