The following data is part of a premarket notification filed by Orthopaedic Innovations, Inc. with the FDA for Prime Femoral Cement Plug.
| Device ID | K955751 |
| 510k Number | K955751 |
| Device Name: | PRIME FEMORAL CEMENT PLUG |
| Classification | Cement Obturator |
| Applicant | ORTHOPAEDIC INNOVATIONS, INC. 825 SOUTH 8TH ST. SUITE 700 Minneapolis, MN 55404 |
| Contact | Carolyn M Steele |
| Correspondent | Carolyn M Steele ORTHOPAEDIC INNOVATIONS, INC. 825 SOUTH 8TH ST. SUITE 700 Minneapolis, MN 55404 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-20 |
| Decision Date | 1996-01-26 |