The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Insite Ft Suture Anchor With Needles.
| Device ID | K132632 |
| 510k Number | K132632 |
| Device Name: | TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | TORNIER, INC. 10801 Nesbitt Avenue South Bloomington, MN 55437 |
| Contact | Janell A Colley |
| Correspondent | Janell A Colley TORNIER, INC. 10801 Nesbitt Avenue South Bloomington, MN 55437 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-22 |
| Decision Date | 2013-09-19 |
| Summary: | summary |