The following data is part of a premarket notification filed by Osteo Technology, Inc. with the FDA for Unifit Femoral Stem.
| Device ID | K922871 |
| 510k Number | K922871 |
| Device Name: | UNIFIT FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-04 |
| Decision Date | 1993-02-12 |