XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM

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

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Xtrafix External Fixation System, Xtrafix Small External Fixation System.

Pre-market Notification Details

Device IDK141697
510k NumberK141697
Device Name:XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactRomil Sheth
CorrespondentRomil Sheth
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-24
Decision Date2014-09-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024080577 K141697 000
00889024080591 K141697 000
00889024080607 K141697 000
00889024080614 K141697 000
00889024080621 K141697 000
00889024080928 K141697 000
00889024081130 K141697 000
00889024080331 K141697 000
00889024080409 K141697 000
00889024080584 K141697 000

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