CONTROL CABLE SYSTEM

Cerclage, Fixation

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Control Cable System.

Pre-market Notification Details

Device IDK934557
510k NumberK934557
Device Name:CONTROL CABLE SYSTEM
ClassificationCerclage, Fixation
Applicant DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactDavid A Kotkovetz
CorrespondentDavid A Kotkovetz
DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-16
Decision Date1994-02-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295067788 K934557 000
10603295067771 K934557 000

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