DELTA HUMERAL CUPS

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 Humeral Cups.

Pre-market Notification Details

Device IDK050315
510k NumberK050315
Device Name:DELTA HUMERAL CUPS
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactTiffani D Rogers
CorrespondentTiffani D Rogers
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-09
Decision Date2005-05-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295170525 K050315 000
10603295170518 K050315 000
10603295170464 K050315 000
10603295170457 K050315 000

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