SIDEKICK EZ FRAME External Fixation System

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

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Sidekick Ez Frame External Fixation System.

Pre-market Notification Details

Device IDK143220
510k NumberK143220
Device Name:SIDEKICK EZ FRAME External Fixation System
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road Memphis,  TN  38117
ContactLeslie Fitch
CorrespondentLeslie Fitch
WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road Memphis,  TN  38117
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-10
Decision Date2015-01-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889797058599 K143220 000
00889797103091 K143220 000
00889797058315 K143220 000
00889797058322 K143220 000
00889797058360 K143220 000
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00889797058469 K143220 000
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00889797058513 K143220 000
00889797058544 K143220 000
00889797058575 K143220 000
00889797058582 K143220 000
00889797066693 K143220 000
00889797066709 K143220 000
00889797066723 K143220 000
00889797103053 K143220 000

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