Submission Details
| 510(k) Number | K213803 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 06, 2021 |
| Decision Date | August 23, 2022 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
FIBERGRAFT Aeridyan Matrix Bone Graft Substitute
Aug 2022
Decision
260d
Days
Class 2
Risk
About This 510(k) Submission
K213803 is an FDA 510(k) clearance for the FIBERGRAFT Aeridyan Matrix Bone Graft Substitute, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Prosidyan, Inc. (New Providence, US). The FDA issued a Cleared decision on August 23, 2022, 260 days after receiving the submission on December 6, 2021. 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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