Submission Details
| 510(k) Number | K251556 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 21, 2025 |
| Decision Date | July 17, 2025 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Device 300423 Granules
Jul 2025
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K251556 is an FDA 510(k) clearance for the Device 300423 Granules, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Geistlich Pharma AG (Wolhusen, CH). The FDA issued a Cleared decision on July 17, 2025, 57 days after receiving the submission on May 21, 2025. 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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