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 |