Reprocessed Stryker External Fixation Devices

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

STRYKER SUSTAINABILITY SOLUTIONS

The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Stryker External Fixation Devices.

Pre-market Notification Details

Device IDK153415
510k NumberK153415
Device Name:Reprocessed Stryker External Fixation Devices
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant STRYKER SUSTAINABILITY SOLUTIONS 1810 W. DRAKE DRIVE Tempe,  AZ  85283
ContactKelli Dryer
CorrespondentKelli Dryer
STRYKER SUSTAINABILITY SOLUTIONS 1810 W. DRAKE DRIVE Tempe,  AZ  85283
Product CodeKTT  
Subsequent Product CodeJEC
Subsequent Product CodeKTW
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-25
Decision Date2016-01-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327323108 K153415 000
07613327303520 K153415 000
07613327303537 K153415 000
07613327303544 K153415 000
07613327303551 K153415 000
07613327303568 K153415 000
07613327303575 K153415 000
07613327303582 K153415 000
07613327303599 K153415 000
07613327323078 K153415 000
07613327323085 K153415 000
07613327323092 K153415 000
07613327303513 K153415 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.