K213342 is an FDA 510(k) clearance for the PRO-DENSE LoVisc Bone Graft Substitute. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on January 5, 2022, 90 days after receiving the submission on October 7, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K213342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2021 |
| Decision Date | January 05, 2022 |
| Days to Decision | 90 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 |