MEMORY METAL STAPLES, EASYCLIP

Staple, Fixation, Bone

STRYKER CORP.

The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Memory Metal Staples, Easyclip.

Pre-market Notification Details

Device IDK122113
510k NumberK122113
Device Name:MEMORY METAL STAPLES, EASYCLIP
ClassificationStaple, Fixation, Bone
Applicant STRYKER CORP. 325 Corporate Drive Mahwah,  NJ  07430
ContactEstela Celi
CorrespondentEstela Celi
STRYKER CORP. 325 Corporate Drive Mahwah,  NJ  07430
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-17
Decision Date2013-03-12
Summary:summary

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