THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER

Fastener, Fixation, Nondegradable, Soft Tissue

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Threvo Suture Anchor With Disposable Driver.

Pre-market Notification Details

Device IDK050227
510k NumberK050227
Device Name:THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactElizabeth M Paul
CorrespondentElizabeth M Paul
LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-01
Decision Date2005-03-02
Summary:summary

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