Submission Details
| 510(k) Number | K190754 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 25, 2019 |
| Decision Date | June 23, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Orthoss(R)
Jun 2019
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K190754 is an FDA 510(k) clearance for the Orthoss(R), 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 June 23, 2019, 90 days after receiving the submission on March 25, 2019. 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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