The following data is part of a premarket notification filed by Tornier with the FDA for Unity Humeral Plate.
| Device ID | K060545 |
| 510k Number | K060545 |
| Device Name: | UNITY HUMERAL PLATE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | TORNIER RUE DOYEN GOSSE St. Ismier, FR 38330 |
| Contact | Mireille Lemery |
| Correspondent | Mireille Lemery TORNIER RUE DOYEN GOSSE St. Ismier, FR 38330 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-01 |
| Decision Date | 2006-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700386928819 | K060545 | 000 |