The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Affiniti Total And Hemi-shoulder System.
| Device ID | K103007 |
| 510k Number | K103007 |
| Device Name: | AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Brahim Hadri |
| Correspondent | Brahim Hadri TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-12 |
| Decision Date | 2010-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832003105 | K103007 | 000 |
| 00846832003013 | K103007 | 000 |
| 00846832003020 | K103007 | 000 |
| 00846832003037 | K103007 | 000 |
| 00846832003044 | K103007 | 000 |
| 00846832003051 | K103007 | 000 |
| 00846832003068 | K103007 | 000 |
| 00846832003075 | K103007 | 000 |
| 00846832003082 | K103007 | 000 |
| 00846832003099 | K103007 | 000 |
| 00846832003006 | K103007 | 000 |