ICONIX ALL SUTURE ANCHORS

Fastener, Fixation, Nondegradable, Soft Tissue

STRYKER CORP.

The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Iconix All Suture Anchors.

Pre-market Notification Details

Device IDK133671
510k NumberK133671
Device Name:ICONIX ALL SUTURE ANCHORS
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant STRYKER CORP. HOWMEDICA OSTEONICS Denver,  CO  80206
ContactKelly Kucharczyk
CorrespondentKelly Kucharczyk
STRYKER CORP. HOWMEDICA OSTEONICS Denver,  CO  80206
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-29
Decision Date2014-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
37613327176934 K133671 000
37613327176927 K133671 000
37613252450369 K133671 000
37613252450352 K133671 000
37613252450345 K133671 000
37613252450338 K133671 000

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