The following data is part of a premarket notification filed by Orthopaedic Innovations, Inc. with the FDA for Prime Modular Endo Head.
| Device ID | K962646 |
| 510k Number | K962646 |
| Device Name: | PRIME MODULAR ENDO HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | ORTHOPAEDIC INNOVATIONS, INC. 825 SOUTH 8TH ST. SUITE 700 Minneapolis, MN 55404 |
| Contact | Carolyn M Steele-husten |
| Correspondent | Carolyn M Steele-husten ORTHOPAEDIC INNOVATIONS, INC. 825 SOUTH 8TH ST. SUITE 700 Minneapolis, MN 55404 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-08 |
| Decision Date | 1996-09-23 |
| Summary: | summary |