Submission Details
| 510(k) Number | K130531 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
ULTRAFUSE
Apr 2014
Decision
403d
Days
Class 2
Risk
About This 510(k) Submission
K130531 is an FDA 510(k) clearance for the ULTRAFUSE, 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 review panel. Regulated under 21 CFR 888.3045.
Device Classification
| Product Code | MQV — Filler, Bone Void, Calcium Compound |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3045 |
Manufacturer
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