SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS

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 Curved-back Pegged All Poly Glenoids.

Pre-market Notification Details

Device IDK970567
510k NumberK970567
Device Name:SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Applicant INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
ContactMitchell A Dhority
CorrespondentMitchell A Dhority
INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeKWT  
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-13
Decision Date1997-02-27
Summary:summary

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