THACKRAY TOTAL CONDYLAR KNEES

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

THACKRAY USA

The following data is part of a premarket notification filed by Thackray Usa with the FDA for Thackray Total Condylar Knees.

Pre-market Notification Details

Device IDK855166
510k NumberK855166
Device Name:THACKRAY TOTAL CONDYLAR KNEES
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant THACKRAY USA R.D. #3 BOX 237 WELISEWITZ RD. Ringoes,  NJ  08551
ContactSer.
CorrespondentSer.
THACKRAY USA R.D. #3 BOX 237 WELISEWITZ RD. Ringoes,  NJ  08551
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-26
Decision Date1986-03-13

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