The following data is part of a premarket notification filed by Revisios Bv with the FDA for Osopia Synthetic Bone Void Filler.
| Device ID | K201546 |
| 510k Number | K201546 |
| Device Name: | OsOpia Synthetic Bone Void Filler |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | RevisiOs BV Professor Bronkhorstlaan 10, Building 48 3723 Mb Bilthoven, NL |
| Contact | Hen Baron |
| Correspondent | Kathy Remsen MRC Global 9085 East Mineral Circle, Suite 110 Centennial, CO 80112 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-09 |
| Decision Date | 2020-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08720165038107 | K201546 | 000 |
| 08720165038091 | K201546 | 000 |
| 08720165038077 | K201546 | 000 |
| 08720165038084 | K201546 | 000 |