The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Perfecta Ii Total Hip System.
| Device ID | K883618 |
| 510k Number | K883618 |
| Device Name: | PERFECTA II TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-24 |
| Decision Date | 1988-12-28 |