The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for P.f.c. Hip System Non-porous Acetabular Component.
Device ID | K902137 |
510k Number | K902137 |
Device Name: | P.F.C. HIP SYSTEM NON-POROUS ACETABULAR 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 | 1990-05-11 |
Decision Date | 1990-06-26 |