The following data is part of a premarket notification filed by Orthopaedic Device Corp. with the FDA for Femoral Hemi-hip Prostheses.
| Device ID | K855228 |
| 510k Number | K855228 |
| Device Name: | FEMORAL HEMI-HIP PROSTHESES |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | ORTHOPAEDIC DEVICE CORP. 6 FOREST AVE. Paramus, NJ 07652 |
| Contact | Alex Khowaylo |
| Correspondent | Alex Khowaylo ORTHOPAEDIC DEVICE CORP. 6 FOREST AVE. Paramus, NJ 07652 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-30 |
| Decision Date | 1986-02-11 |