Submission Details
| 510(k) Number | K180080 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 10, 2018 |
| Decision Date | April 06, 2018 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
FIBERGRAFT BG Matrix Bone Graft Substitute
Apr 2018
Decision
86d
Days
Class 2
Risk
About This 510(k) Submission
K180080 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 April 6, 2018, 86 days after receiving the submission on January 10, 2018. 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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