Submission Details
| 510(k) Number | K132805 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 06, 2013 |
| Decision Date | March 14, 2014 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
BG MORSELS
Mar 2014
Decision
189d
Days
Class 2
Risk
About This 510(k) Submission
K132805 is an FDA 510(k) clearance for the 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 March 14, 2014, 189 days after receiving the submission on September 6, 2013. 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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