The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Perfecta Total Hip System, Ceramic Femoral Head.
| Device ID | K921836 |
| 510k Number | K921836 |
| Device Name: | PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Contact | Dennis Crane |
| Correspondent | Dennis Crane ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-17 |
| Decision Date | 1992-11-06 |