K130531 is an FDA 510(k) clearance for the ULTRAFUSE. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by Baxter Healthcare Corp (Westlake Village, US). The FDA issued a Cleared decision on April 8, 2014, 403 days after receiving the submission on March 1, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K130531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2013 |
| Decision Date | April 08, 2014 |
| Days to Decision | 403 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 |