SELECT(R) SHOULDER 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(r) Shoulder All-poly Glenoid.

Pre-market Notification Details

Device IDK931114
510k NumberK931114
Device Name:SELECT(R) SHOULDER ALL-POLY GLENOID
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactJoann Ringer
CorrespondentJoann Ringer
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeKWT  
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-04
Decision Date1994-05-09

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