K122635 is an FDA 510(k) clearance for the TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR. This device is classified as a Fastener, Fixation, Biodegradable, Soft Tissue (Class II - Special Controls, product code MAI).
Submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on May 13, 2013, 257 days after receiving the submission on August 29, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K122635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2012 |
| Decision Date | May 13, 2013 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MAI — Fastener, Fixation, Biodegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |