REVERSE SHOULDER PROSTHESIS

Shoulder Prosthesis, Reverse Configuration

DJO SURGICAL

The following data is part of a premarket notification filed by Djo Surgical with the FDA for Reverse Shoulder Prosthesis.

Pre-market Notification Details

Device IDK092873
510k NumberK092873
Device Name:REVERSE SHOULDER PROSTHESIS
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant DJO SURGICAL 9800 METRIC BOULEVARD Austin,  TX  78758
ContactTeffany Hutto
CorrespondentTeffany Hutto
DJO SURGICAL 9800 METRIC BOULEVARD Austin,  TX  78758
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-18
Decision Date2009-10-27
Summary:summary

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