The following data is part of a premarket notification filed by Orthopaedic Device Corp. with the FDA for Femoral Hemi-hip Prosthesis.
| Device ID | K862460 |
| 510k Number | K862460 |
| Device Name: | FEMORAL HEMI-HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | ORTHOPAEDIC DEVICE CORP. C/O COLE GEANEY YAMNER & BYRNE P.O. BOX D 100 HAMILTON PLAZA Paterson, NJ 07509 |
| Contact | Alex Khowaylo |
| Correspondent | Alex Khowaylo ORTHOPAEDIC DEVICE CORP. C/O COLE GEANEY YAMNER & BYRNE P.O. BOX D 100 HAMILTON PLAZA Paterson, NJ 07509 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-30 |
| Decision Date | 1986-10-06 |