STRYKER PEEK ZIP SUTURE ANCHOR

Fastener, Fixation, Nondegradable, Soft Tissue

Stryker Endoscopy

The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Peek Zip Suture Anchor.

Pre-market Notification Details

Device IDK070758
510k NumberK070758
Device Name:STRYKER PEEK ZIP SUTURE ANCHOR
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Stryker Endoscopy 5900 OPTICAL CT. San Jose,  CA  95138
ContactErica A Walters
CorrespondentErica A Walters
Stryker Endoscopy 5900 OPTICAL CT. San Jose,  CA  95138
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-20
Decision Date2007-05-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
37613252232491 K070758 000
37613154644552 K070758 000
37613154644545 K070758 000
37613154644538 K070758 000
37613154644521 K070758 000

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