DEPUY CTA REVERSE SHOULDER SYSTEM

Shoulder Prosthesis, Reverse Configuration

DEPUY FRANCE

The following data is part of a premarket notification filed by Depuy France with the FDA for Depuy Cta Reverse Shoulder System.

Pre-market Notification Details

Device IDK122442
510k NumberK122442
Device Name:DEPUY CTA REVERSE SHOULDER SYSTEM
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant DEPUY FRANCE 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46580
ContactMegan Burns
CorrespondentMegan Burns
DEPUY FRANCE 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46580
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-10
Decision Date2012-09-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295423720 K122442 000
10603295423713 K122442 000
10603295423706 K122442 000
10603295423690 K122442 000
10603295423683 K122442 000
10603295423676 K122442 000
10603295423669 K122442 000

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