The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Resurfacing Head.
Device ID | K062661 |
510k Number | K062661 |
Device Name: | AEQUALIS RESURFACING HEAD |
Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
Applicant | TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334 |
Contact | Mireille Lemery |
Correspondent | Mireille Lemery TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334 |
Product Code | HSD |
CFR Regulation Number | 888.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-07 |
Decision Date | 2006-12-22 |
Summary: | summary |