SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5 / 4.5 Mm Lcp Metaphyseal Plates.

Pre-market Notification Details

Device IDK033805
510k NumberK033805
Device Name:SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactLisa M Boyle
CorrespondentLisa M Boyle
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeLXT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-08
Decision Date2004-02-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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H6792234120 K033805 000
H6792234140 K033805 000
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H6794234060 K033805 000

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