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 |