The following data is part of a premarket notification filed by Thackray Usa with the FDA for Thackray Total Condylar Knees.
| Device ID | K855166 |
| 510k Number | K855166 |
| Device Name: | THACKRAY TOTAL CONDYLAR KNEES |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | THACKRAY USA R.D. #3 BOX 237 WELISEWITZ RD. Ringoes, NJ 08551 |
| Contact | Ser. |
| Correspondent | Ser. THACKRAY USA R.D. #3 BOX 237 WELISEWITZ RD. Ringoes, NJ 08551 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-26 |
| Decision Date | 1986-03-13 |