The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for S-rom Zirconia Ceramic Femoral Hip Head.
| Device ID | K980081 |
| 510k Number | K980081 |
| Device Name: | S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Mary E Gray |
| Correspondent | Mary E Gray JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. 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 | 1998-01-09 |
| Decision Date | 1998-04-09 |
| Summary: | summary |