The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Gross Hip Femoral Component.
Device ID | K904737 |
510k Number | K904737 |
Device Name: | GROSS HIP FEMORAL COMPONENT |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | JOHNSON & JOHNSON ORTHOPAEDICS, INC. Braintree, MA 02184 |
Contact | J Stone |
Correspondent | J Stone JOHNSON & JOHNSON ORTHOPAEDICS, INC. Braintree, MA 02184 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-18 |
Decision Date | 1991-07-26 |