The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Cinch Knotless Fixation Implant System.
| Device ID | K080335 |
| 510k Number | K080335 |
| Device Name: | TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Howard Schrayer |
| Correspondent | Howard Schrayer TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-07 |
| Decision Date | 2008-04-23 |
| Summary: | summary |