The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Porous Coated Acetabular Cup.
| Device ID | K873585 |
| 510k Number | K873585 |
| Device Name: | POROUS COATED ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-04 |
| Decision Date | 1987-10-28 |