BIOSURE HEALICOIL PK INTERFERENCE SCREW

Fastener, Fixation, Nondegradable, Soft Tissue

Smith & Nephew, Inc

The following data is part of a premarket notification filed by Smith & Nephew, Inc with the FDA for Biosure Healicoil Pk Interference Screw.

Pre-market Notification Details

Device IDK140879
510k NumberK140879
Device Name:BIOSURE HEALICOIL PK INTERFERENCE SCREW
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Smith & Nephew, Inc 150 MINUTEMAN DR. Andover,  MA  01810
ContactVivek Mukhatyar
CorrespondentVivek Mukhatyar
Smith & Nephew, Inc 150 MINUTEMAN DR. Andover,  MA  01810
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-07
Decision Date2014-07-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885556541234 K140879 000
00885556541197 K140879 000
00885556541173 K140879 000
00885556541142 K140879 000

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