The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier, Inc., Insite Suture Anchors.
| Device ID | K083268 |
| 510k Number | K083268 |
| Device Name: | TORNIER, INC., INSITE SUTURE ANCHORS |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-05 |
| Decision Date | 2009-02-12 |
| Summary: | summary |