SYNTHES LCP DISTAL TIBIA PLATES

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Lcp Distal Tibia Plates.

Pre-market Notification Details

Device IDK013248
510k NumberK013248
Device Name:SYNTHES LCP DISTAL TIBIA PLATES
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactMatthew M Hull
CorrespondentMatthew M Hull
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-28
Decision Date2001-12-19
Summary:summary

NIH GUDID Devices

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