K062607 is an FDA 510(k) clearance for the POLYGRAFT BGS. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on November 9, 2007, 430 days after receiving the submission on September 5, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K062607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | September 05, 2006 |
| Decision Date | November 09, 2007 |
| Days to Decision | 430 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MQV — Filler, Bone Void, Calcium Compound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3045 |