The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Perfecta Total Hip System, Hemi-head Component.
| Device ID | K915868 |
| 510k Number | K915868 |
| Device Name: | PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| 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 | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-30 |
| Decision Date | 1992-03-23 |