SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL 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 (usa) 2.7mm/ 3.5mm Lcp Anterolateral Distal Tibia Plates.

Pre-market Notification Details

Device IDK092812
510k NumberK092812
Device Name:SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactKarl J Nittinger
CorrespondentKarl J Nittinger
SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-14
Decision Date2010-05-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679SD2414530 K092812 000
H679SD2414520 K092812 000
H679SD2414490 K092812 000
H679SD2414480 K092812 000
H679SD2414450 K092812 000
H679SD2414440 K092812 000
H679SD2414430 K092812 000
H679SD2414420 K092812 000

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