STRYKER WEDGE SUTURE ANCHOR SYSTEM

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 Wedge Suture Anchor System.

Pre-market Notification Details

Device IDK041310
510k NumberK041310
Device Name:STRYKER WEDGE SUTURE ANCHOR SYSTEM
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Stryker Endoscopy 5900 OPTICAL CT. San Jose,  CA  95138
ContactMelissa Murphy
CorrespondentMelissa Murphy
Stryker Endoscopy 5900 OPTICAL CT. San Jose,  CA  95138
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-17
Decision Date2004-06-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613154644513 K041310 000
07613154644506 K041310 000
37613154175018 K041310 000
37613154019855 K041310 000
37613154015307 K041310 000

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