The following data is part of a premarket notification filed by Osteo Technology, Inc. with the FDA for Biometric Screw Fixation Cup.
| Device ID | K922861 |
| 510k Number | K922861 |
| Device Name: | BIOMETRIC SCREW FIXATION CUP |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | OSTEO TECHNOLOGY, INC. 10 WEST AYLESBURY RD. Timonium, MD 21093 |
| Contact | Sam Son |
| Correspondent | Sam Son OSTEO TECHNOLOGY, INC. 10 WEST AYLESBURY RD. Timonium, MD 21093 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-04 |
| Decision Date | 1993-05-12 |