The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Insite(tm) Ft Peek Knotless Suture Anchor.
| Device ID | K133777 |
| 510k Number | K133777 |
| Device Name: | TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | TORNIER, INC. 10801 Nesbitt Avenue South Bloomington, MN 55437 |
| Contact | Mireille Lemery |
| Correspondent | Mireille Lemery TORNIER, INC. 10801 Nesbitt Avenue South Bloomington, MN 55437 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-12 |
| Decision Date | 2014-04-04 |
| Summary: | summary |