WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM

Cerclage, Fixation

THACKRAY USA

The following data is part of a premarket notification filed by Thackray Usa with the FDA for Wroblewski Spring Compression Wire System.

Pre-market Notification Details

Device IDK882890
510k NumberK882890
Device Name:WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM
ClassificationCerclage, Fixation
Applicant THACKRAY USA R.D. #3 BOX 237 WELISEWITZ RD. Ringoes,  NJ  08551
ContactRandolph L Cooke
CorrespondentRandolph L Cooke
THACKRAY USA R.D. #3 BOX 237 WELISEWITZ RD. Ringoes,  NJ  08551
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-11
Decision Date1988-08-08

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