The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Ultima(tm) Total Hip System Cemented Femoral Stem.
Device ID | K924379 |
510k Number | K924379 |
Device Name: | ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
Applicant | JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
Contact | Marsha J Stone |
Correspondent | Marsha J Stone JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
Product Code | KWL |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-31 |
Decision Date | 1993-02-12 |