SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL 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) 3.5mm Lcp Posteromedial Proximal Tibia Plates.

Pre-market Notification Details

Device IDK082624
510k NumberK082624
Device Name:SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL 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 Received2008-09-09
Decision Date2008-11-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H67902120710S0 K082624 000
H679041207100 K082624 000
H67904120708S0 K082624 000
H679041207080 K082624 000
H67904120706S0 K082624 000
H679041207060 K082624 000
H67904120704S0 K082624 000
H679041207040 K082624 000
H67904120702S0 K082624 000
H679041207020 K082624 000
H67904120701S0 K082624 000
H67904120710S0 K082624 000
H679021207010 K082624 000
H679021207100 K082624 000
H67902120708S0 K082624 000
H679021207080 K082624 000
H67902120706S0 K082624 000
H679021207060 K082624 000
H67902120704S0 K082624 000
H679021207040 K082624 000
H67902120702S0 K082624 000
H679021207020 K082624 000
H67902120701S0 K082624 000
H679041207010 K082624 000

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