The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for P.f.c. 2 Total Hip System Porous Coated Modular Femoral Component.
Device ID | K935452 |
510k Number | K935452 |
Device Name: | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | JOHNSON & JOHNSON ORTHOPAEDICS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | Marsha J Stone |
Correspondent | Marsha J Stone JOHNSON & JOHNSON ORTHOPAEDICS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-12 |
Decision Date | 1994-10-06 |