NEER-III GLENOID RESURFACING PROSTHESIS

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

KIRSCHNER MEDICAL CORP.

The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Neer-iii Glenoid Resurfacing Prosthesis.

Pre-market Notification Details

Device IDK873104
510k NumberK873104
Device Name:NEER-III GLENOID RESURFACING PROSTHESIS
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Applicant KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium,  MD  21093
ContactSam Son
CorrespondentSam Son
KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium,  MD  21093
Product CodeKWT  
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-07
Decision Date1987-10-15

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