The following data is part of a premarket notification filed by Geistlich-pharma with the FDA for Orthoss Resorbable Bone Void Filler.
| Device ID | K014289 |
| 510k Number | K014289 |
| Device Name: | ORTHOSS RESORBABLE BONE VOID FILLER |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | GEISTLICH-PHARMA 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz GEISTLICH-PHARMA 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-28 |
| Decision Date | 2002-03-28 |