Submission Details
| 510(k) Number | K171284 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 01, 2017 |
| Decision Date | June 30, 2017 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
FIBERGRAFT BG Matrix Bone Graft Substitute
Jun 2017
Decision
60d
Days
Class 2
Risk
About This 510(k) Submission
K171284 is an FDA 510(k) clearance for the FIBERGRAFT BG Matrix 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 June 30, 2017, 60 days after receiving the submission on May 1, 2017. 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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