SELECT SHOULDER SYSTEM

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 System.

Pre-market Notification Details

Device IDK873679
510k NumberK873679
Device Name:SELECT SHOULDER SYSTEM
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactThomas Craig
CorrespondentThomas Craig
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeHSD  
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-14
Decision Date1987-11-17

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