The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Orthoss(r).
| Device ID | K190754 |
| 510k Number | K190754 |
| Device Name: | Orthoss(R) |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen, CH Ch-6110 |
| Contact | Marco Steiner |
| Correspondent | Roshana Ahmed TELOS Partners, LLC 571 Christina Lake Drive Lakeland, FL 33813 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-25 |
| Decision Date | 2019-06-23 |