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 Small External Fixation System.

Pre-market Notification Details

Device IDK131413
510k NumberK131413
Device Name:XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant 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 Received2013-05-16
Decision Date2014-01-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024080324 K131413 000
00889024080775 K131413 000
00889024080799 K131413 000
00889024080805 K131413 000
00889024080829 K131413 000
00889024080843 K131413 000
00889024081420 K131413 000
00889024081437 K131413 000
00889024081444 K131413 000
00889024081451 K131413 000
00889024081468 K131413 000
00889024081475 K131413 000
00889024080294 K131413 000
00889024080300 K131413 000
00889024080317 K131413 000
00889024080768 K131413 000

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