SUPER REVO SUTURE ANCHOR

Fastener, Fixation, Biodegradable, Soft Tissue

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Super Revo Suture Anchor.

Pre-market Notification Details

Device IDK003984
510k NumberK003984
Device Name:SUPER REVO SUTURE ANCHOR
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactLaura D Seneff
CorrespondentLaura D Seneff
LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
Product CodeMAI  
Subsequent Product CodeGAS
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-26
Decision Date2001-03-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20845854019815 K003984 000
20845854012311 K003984 000

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