DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS

Shoulder Prosthesis, Reverse Configuration

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Delta Cta Reverse Shoulder System Humeral Heads.

Pre-market Notification Details

Device IDK062116
510k NumberK062116
Device Name:DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactRhonda Myer
CorrespondentRhonda Myer
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-25
Decision Date2006-08-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295265429 K062116 000
10603295265412 K062116 000
10603295265405 K062116 000
10603295265399 K062116 000

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