The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for P.f.c. Total Hip System Porous Coated Modular Acet.
| Device ID | K931189 |
| 510k Number | K931189 |
| Device Name: | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-09 |
| Decision Date | 1994-02-09 |