SELECT SHOULDER COCR HUMERAL STEM COMPONENT

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Select Shoulder Cocr Humeral Stem Component.

Pre-market Notification Details

Device IDK962289
510k NumberK962289
Device Name:SELECT SHOULDER COCR HUMERAL STEM COMPONENT
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
ContactMitchell A Dhority
CorrespondentMitchell A Dhority
INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeHSD  
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-14
Decision Date1996-08-29
Summary:summary

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