Submission Details
| 510(k) Number | K141956 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 18, 2014 |
| Decision Date | August 13, 2014 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Special
FIBERGRAFT BG MORSELS
Aug 2014
Decision
26d
Days
Class 2
Risk
About This 510(k) Submission
K141956 is an FDA 510(k) clearance for the FIBERGRAFT BG MORSELS, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Prosidyan, Inc. (Philedelphia, US). The FDA issued a Cleared decision on August 13, 2014, 26 days after receiving the submission on July 18, 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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