K091302 is an FDA 510(k) clearance for the INTEGRA MOZAIK AND OS MOLDABLE MORSELS. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on December 4, 2009, 214 days after receiving the submission on May 4, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K091302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2009 |
| Decision Date | December 04, 2009 |
| Days to Decision | 214 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 |