SUPER REVO HERCULINE SUTURE ANCHOR

Fastener, Fixation, Nondegradable, Soft Tissue

LINVATEC CORP.

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

Pre-market Notification Details

Device IDK041713
510k NumberK041713
Device Name:SUPER REVO HERCULINE SUTURE ANCHOR
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 Received2004-06-23
Decision Date2004-07-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20845854019822 K041713 000
20845854015848 K041713 000
20845854042448 K041713 000
20845854042431 K041713 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.