NEER TYPE SHOULDER PROSTHESIS SYSTEM

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

OSTEO TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Osteo Technology, Inc. with the FDA for Neer Type Shoulder Prosthesis System.

Pre-market Notification Details

Device IDK922865
510k NumberK922865
Device Name:NEER TYPE SHOULDER PROSTHESIS SYSTEM
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Applicant OSTEO TECHNOLOGY, INC. 10 WEST AYLESBURY RD. Timonium,  MD  21093
ContactSam Son
CorrespondentSam Son
OSTEO TECHNOLOGY, INC. 10 WEST AYLESBURY RD. Timonium,  MD  21093
Product CodeKWT  
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-04
Decision Date1992-12-10

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