ORTHOMET PIN SYSTEM

Pin, Fixation, Smooth

ORTHOMET, INC.

The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Orthomet Pin System.

Pre-market Notification Details

Device IDK874913
510k NumberK874913
Device Name:ORTHOMET PIN SYSTEM
ClassificationPin, Fixation, Smooth
Applicant ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis,  MN  55439 -2713
ContactAl Lippincott
CorrespondentAl Lippincott
ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis,  MN  55439 -2713
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-03
Decision Date1988-01-07

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