The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Steri-oss Screw Style Itianium Implant.
| Device ID | K924121 |
| 510k Number | K924121 |
| Device Name: | STERI-OSS SCREW STYLE ITIANIUM IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERI-OSS, INC. 901 EAST CERRITOS AVE. Anaheim, CA 92805 |
| Contact | Don Kennard |
| Correspondent | Don Kennard STERI-OSS, INC. 901 EAST CERRITOS AVE. Anaheim, CA 92805 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-14 |
| Decision Date | 1993-12-10 |