K061668 is an FDA 510(k) clearance for the OPTECURE +CCC. This device is classified as a Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (Class II - Special Controls, product code MBP).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on September 12, 2006, 90 days after receiving the submission on June 14, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K061668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2006 |
| Decision Date | September 12, 2006 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBP — Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3045 |