The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for P.f.c. Ceramic Hip Head.
Device ID | K933275 |
510k Number | K933275 |
Device Name: | P.F.C. CERAMIC HIP HEAD |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
Contact | Caroline F Lee |
Correspondent | Caroline F Lee JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-06 |
Decision Date | 1994-09-28 |