FDA 510(k) Applications for Medical Device:
Prosthesis, Wrist, Carpal Trapezium
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K061954 |
ARTIMPLANT AB |
719 A STREET NE
| WASHINGTON |
DC |
20002 |
K040070 |
ARTIMPLANT AB |
719 A STREET NE
| WASHINGTON |
DC |
20002 |
K061956 |
ARTIMPLANT AB |
719 A STREET NE
| WASHINGTON |
DC |
20002 |
K112278 |
ASCENSION ORTHOPEDIC |
8700 CAMERON RD., STE. 100
| Austin |
TX |
78754 |
K041451 |
ASCENSION ORTHOPEDICS, INC. |
8200 CAMERON RD., SUITE C-140
| AUSTIN |
TX |
78754-3832 |
K042690 |
ASCENSION ORTHOPEDICS, INC. |
8200 CAMERON RD., SUITE C-140
| AUSTIN |
TX |
78754-3832 |
K061451 |
ASCENSION ORTHOPEDICS, INC. |
8700 CAMERON RD., STE. 100
| AUSTIN |
TX |
78754-3832 |
K964381 |
AVANTA ORTHOPAEDICS, INC. |
9369 CARROLL PARK DRIVE, STE.A
| SAN DIEGO |
CA |
92121 |
K965204 |
AVANTA ORTHOPAEDICS, INC. |
9369 CARROLL PARK DRIVE, STE.A
| SAN DIEGO |
CA |
92121 |
K964472 |
BIOLOGICALLY ORIENTED PROSTHESES |
17 SEVENTEENTH ST.
| PORT HURON |
MI |
48060 |
K052596 |
BIOPRO, INC. |
17 SEVENTEENTH ST.
| PORT HURON |
MI |
48060 |
K061089 |
BIOPRO, INC. |
17 SEVENTEENTH ST.
| PORT HURON |
MI |
48060 |
K201072 |
Ensemble Orthopedics, LLC |
107 Redbud Trail, Suite 11
| Austin |
TX |
78746 |
K092548 |
EXTREMITY MEDICAL LLC |
300 INTERPACE PARKWAY
| PARSIPPANY |
NJ |
07054 |
K060386 |
NEXA ORTHOPEDICS, INC. |
10675 SORRENTO VALLEY ROAD
| SAN DIEGO |
CA |
92121 |
K111068 |
SKELETAL DYNAMICS, LLC |
8905 SW 87 AVENUE, SUITE 201
| MIAMI |
FL |
33176 |
K180744 |
Skeletal Dynamics, LLC |
8905 SW 87 Avenue, Suite 201
| Miami |
FL |
33176 |
K960659 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD.
| ARLINGTON |
TN |
38002 |
K960534 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD.
| ARLINGTON |
TN |
38002 |
K033529 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD.
| ARLINGTON |
TN |
38002 |
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