The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Steri-oss Screw Style Cp Titanium Implant.
| Device ID | K923695 |
| 510k Number | K923695 |
| Device Name: | STERI-OSS SCREW STYLE CP TITANIUM 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 | 1992-07-23 |
| Decision Date | 1993-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747034691 | K923695 | 000 |
| 07332747003680 | K923695 | 000 |
| 07332747003697 | K923695 | 000 |
| 07332747003703 | K923695 | 000 |
| 07332747003710 | K923695 | 000 |
| 07332747003727 | K923695 | 000 |
| 07332747003734 | K923695 | 000 |
| 07332747003741 | K923695 | 000 |
| 07332747003758 | K923695 | 000 |
| 07332747003765 | K923695 | 000 |
| 07332747003772 | K923695 | 000 |
| 07332747003789 | K923695 | 000 |
| 07332747003796 | K923695 | 000 |
| 07332747003802 | K923695 | 000 |
| 07332747024036 | K923695 | 000 |
| 07332747034684 | K923695 | 000 |
| 07332747003673 | K923695 | 000 |