K102545 is an FDA 510(k) clearance for the FM-02 BONE GRAFT SUBSTITUTE. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by Orthovita, Inc. (Malver, US). The FDA issued a Cleared decision on October 27, 2010, 54 days after receiving the submission on September 3, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K102545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2010 |
| Decision Date | October 27, 2010 |
| Days to Decision | 54 days |
| Submission Type | Special |
| 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 |