The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for S-rom Hip System - Locking Plug.
| Device ID | K963206 |
| 510k Number | K963206 |
| Device Name: | S-ROM HIP SYSTEM - LOCKING PLUG |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Jennifer L Morse |
| Correspondent | Jennifer L Morse JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-16 |
| Decision Date | 1996-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295175162 | K963206 | 000 |
| 10603295175155 | K963206 | 000 |