The following data is part of a premarket notification filed by Orthopaedic Innovations, Inc. with the FDA for Prime Cemented Hip System.
| Device ID | K940328 |
| 510k Number | K940328 |
| Device Name: | PRIME CEMENTED HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ORTHOPAEDIC INNOVATIONS, INC. 825 SOUTH 8TH ST. SUITE 700 Minneapolis, MN 55404 |
| Contact | Nicholas A Gustilo |
| Correspondent | Nicholas A Gustilo ORTHOPAEDIC INNOVATIONS, INC. 825 SOUTH 8TH ST. SUITE 700 Minneapolis, MN 55404 |
| 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 | 1994-01-24 |
| Decision Date | 1995-04-07 |