The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Orthomet Perfecta Total Hip System.
| Device ID | K923583 |
| 510k Number | K923583 |
| Device Name: | ORTHOMET PERFECTA TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Contact | David Cannistraci |
| Correspondent | David Cannistraci ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-20 |
| Decision Date | 1992-12-07 |