K142948 is an FDA 510(k) clearance for the BIOSURE REGENESORB interference Screw. This device is classified as a Fastener, Fixation, Biodegradable, Soft Tissue (Class II - Special Controls, product code MAI).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on January 13, 2015, 95 days after receiving the submission on October 10, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K142948 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2014 |
| Decision Date | January 13, 2015 |
| Days to Decision | 95 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 |