FDA 510(k) Applications for Medical Device:
Prosthesis, Elbow, Semi-Constrained, Cemented
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K972691 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K983141 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K222807 | LimaCorporate S.p.A. |
Via Nazionale 52 | Villanova di San Daniele del Friuli | 33038 | |
| K060038 | SMALL BONE INNOVATIONS INC. |
505 PARK AVE., 14TH FLOOR | NEW YORK | NY | 10022 |
| K102180 | SMALL BONE INNOVATIONS, INC. |
1380 S. PENNSYLVANIA AVE. | MORRISVILLE | PA | 19067 |
| K070236 | SMALL BONE INNOVATIONS, INC. |
505 PARK AVENUE, 14TH FLOOR | NEWYORK | NY | |
| K070787 | TORNIER |
161 RUE LAVOISIER | SAINT-ISMIER CEDEX | 38334 | |
| K031218 | TORNIER |
ZIRST-161, RUE LAVOISIER | MONTBONNOT | 38330 | |
| K060438 | TORNIER |
161 RUE LAVOISIER | MONTBONNOT, SAINT-ISMIER | 38334 | |
| K050848 | TORNIER |
161 RUE LAVOISIER | MONTBONNOT, SAINT-ISMIER | 38334 | |
| K011567 | TORNIER |
ZIRST-161, RUE LAVOISIER | MONTBONNOT | 38330 | |
| K171010 | Tornier Inc. |
10801 Nesbitt Ave South | Bloomington | MN | 55437 |
| K182461 | Tornier Inc. |
10801 Nesbitt Ave South | Bloomington | MN | 55437 |
| K193247 | Tornier Inc. |
10801 Nesbitt Ave South | Bloomington | MN | 55347 |
| K100562 | TORNIER, INC. |
100 CUMMINGS CENTER | BEVERLY | MA | 01915 |
| K955099 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K960087 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
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