The following data is part of a premarket notification filed by Orthopaedic Innovations, Inc. with the FDA for Prime Cemented Calcar Femoral Stems.
Device ID | K955620 |
510k Number | K955620 |
Device Name: | PRIME CEMENTED CALCAR FEMORAL STEMS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
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 | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-11 |
Decision Date | 1996-02-20 |