2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445

Fastener, Fixation, Biodegradable, Soft Tissue

LINVATEC BIOMATERIALS, LTD.

The following data is part of a premarket notification filed by Linvatec Biomaterials, Ltd. with the FDA for 2.4 Smartnail, Models 532416, 532425, 532435, 532445.

Pre-market Notification Details

Device IDK031981
510k NumberK031981
Device Name:2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant LINVATEC BIOMATERIALS, LTD. 1311 CONCEPT BLVD Largo,  FL  33773
ContactLaura Krejci
CorrespondentLaura Krejci
LINVATEC BIOMATERIALS, LTD. 1311 CONCEPT BLVD Largo,  FL  33773
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-26
Decision Date2003-07-25
Summary:summary

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