The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for 2.5mm Insite Ft Suture Anchors , 3.5mm Insite Ft Suture Anchors.
| Device ID | K150715 |
| 510k Number | K150715 |
| Device Name: | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | TORNIER, INC. 10801 NESBITT AVENUE SOUTH Bloomington, MN 55437 |
| Contact | Kaitlyn Rainbow |
| Correspondent | Kaitlyn Rainbow 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 | Yes |
| Date Received | 2015-03-19 |
| Decision Date | 2015-07-28 |
| Summary: | summary |