MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR

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 Modification To: Sterile Colles Classic Fixator.

Pre-market Notification Details

Device IDK013503
510k NumberK013503
Device Name:MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
ContactMarcia J Arentz
CorrespondentMarcia J Arentz
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-22
Decision Date2001-11-16
Summary:summary

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