The following data is part of a premarket notification filed by Thackray Usa with the FDA for Elite Modular Hip System.
| Device ID | K871867 |
| 510k Number | K871867 |
| Device Name: | ELITE MODULAR HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | THACKRAY USA R.D. #3 BOX 237 WELISEWITZ RD. Ringoes, NJ 08551 |
| Contact | Randolph L Cooke |
| Correspondent | Randolph L Cooke THACKRAY USA R.D. #3 BOX 237 WELISEWITZ RD. Ringoes, NJ 08551 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-13 |
| Decision Date | 1988-04-08 |