K083635 is an FDA 510(k) clearance for the SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).
Submitted by Smith & Nephew Endoscopy, Inc. (Andover, US). The FDA issued a Cleared decision on January 30, 2009, 53 days after receiving the submission on December 8, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K083635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2008 |
| Decision Date | January 30, 2009 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBI — Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |