The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Steri-oss Titanium Screw Series Implant.
| Device ID | K923484 |
| 510k Number | K923484 |
| Device Name: | STERI-OSS TITANIUM SCREW SERIES 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 | 1992-07-15 |
| Decision Date | 1993-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747016185 | K923484 | 000 |
| 07332747088052 | K923484 | 000 |
| 07332747004335 | K923484 | 000 |
| 07332747004342 | K923484 | 000 |
| 07332747004359 | K923484 | 000 |
| 07332747004366 | K923484 | 000 |
| 07332747004373 | K923484 | 000 |
| 07332747004380 | K923484 | 000 |
| 07332747004397 | K923484 | 000 |
| 07332747016130 | K923484 | 000 |
| 07332747016147 | K923484 | 000 |
| 07332747016154 | K923484 | 000 |
| 07332747016161 | K923484 | 000 |
| 07332747016178 | K923484 | 000 |
| 07332747088007 | K923484 | 000 |