SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION

Plate, Fixation, Bone

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK052390
510k NumberK052390
Device Name:SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactLisa Boyle
CorrespondentLisa Boyle
SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-31
Decision Date2005-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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H679240055S0 K052390 000

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