TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE

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

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Tempfix External Fixation System, Mr Safe.

Pre-market Notification Details

Device IDK043113
510k NumberK043113
Device Name:TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactClaudia S Swanson
CorrespondentClaudia S Swanson
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-10
Decision Date2005-01-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887868034640 K043113 000
00887868034633 K043113 000
00887868034565 K043113 000

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