SELECT SHOULDER PEGGED ALL-POLY GLENOID

Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Select Shoulder Pegged All-poly Glenoid.

Pre-market Notification Details

Device IDK962244
510k NumberK962244
Device Name:SELECT SHOULDER PEGGED ALL-POLY GLENOID
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Applicant INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
ContactMitchel A Dhority
CorrespondentMitchel A Dhority
INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeKWT  
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-11
Decision Date1996-08-09
Summary:summary

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