Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM

Fastener, Fixation, Nondegradable, Soft Tissue

LINVATEC CORPORATION D/B/A CONMED LINVATEC

The following data is part of a premarket notification filed by Linvatec Corporation D/b/a Conmed Linvatec with the FDA for Y-knot Flex All-suture Anchor, W/ Two #2 (5 Metric) Hi-fi Sutures, 1.8mm.

Pre-market Notification Details

Device IDK131035
510k NumberK131035
Device Name:Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo,  FL  33773
ContactJoy Lovett
CorrespondentJoy Lovett
LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo,  FL  33773
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-12
Decision Date2013-07-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20845854606091 K131035 000
10845854044735 K131035 000
20653405986765 K131035 000
20653405986772 K131035 000
20845854050689 K131035 000
20845854850654 K131035 000
20845854021672 K131035 000
20845854041793 K131035 000
20845854042004 K131035 000
20845854042028 K131035 000
10845854044728 K131035 000

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