The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Bipolar Hip System.
| Device ID | K892398 |
| 510k Number | K892398 |
| Device Name: | BIPOLAR HIP SYSTEM |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| Applicant | ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Contact | Dennis H Crane |
| Correspondent | Dennis H Crane ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Product Code | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-07 |
| Decision Date | 1989-05-23 |