The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Steri-oss Titanium Alloy Screw Series Implant For Single Stage Surgical Placement.
| Device ID | K944158 |
| 510k Number | K944158 |
| Device Name: | STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Contact | Jeff W Hausheer |
| Correspondent | Jeff W Hausheer STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-26 |
| Decision Date | 1995-03-29 |