Submission Details
| 510(k) Number | K241802 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 21, 2024 |
| Decision Date | November 08, 2024 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Device 300397 Putty
Nov 2024
Decision
140d
Days
Class 2
Risk
About This 510(k) Submission
K241802 is an FDA 510(k) clearance for the Device 300397 Putty, 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 November 8, 2024, 140 days after receiving the submission on June 21, 2024. 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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