Submission Details
| 510(k) Number | K143533 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 12, 2014 |
| Decision Date | March 25, 2015 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE
Mar 2015
Decision
103d
Days
Class 2
Risk
About This 510(k) Submission
K143533 is an FDA 510(k) clearance for the FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Prosidyan, Inc. (Warren, US). The FDA issued a Cleared decision on March 25, 2015, 103 days after receiving the submission on December 12, 2014. 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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