K181255 is an FDA 510(k) clearance for the PRODENSE 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 September 12, 2018, 124 days after receiving the submission on May 11, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K181255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2018 |
| Decision Date | September 12, 2018 |
| Days to Decision | 124 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 |