K181746 is an FDA 510(k) clearance for the MICRORAPTOR Knotless Suture Anchor. This device is classified as a Fastener, Fixation, Biodegradable, Soft Tissue (Class II - Special Controls, product code MAI).
Submitted by Smith and Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on September 28, 2018, 88 days after receiving the submission on July 2, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K181746 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2018 |
| Decision Date | September 28, 2018 |
| Days to Decision | 88 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 |