KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS

Appliance, Fixation, Spinal Intervertebral Body

ACROMED CORP.

The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Kaneda Anterior Scoliosis System Kass.

Pre-market Notification Details

Device IDK974757
510k NumberK974757
Device Name:KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant ACROMED CORP. 3303 CARNEGIE AVE. Cleveland,  OH  44115
ContactGreg Cannedy
CorrespondentGreg Cannedy
ACROMED CORP. 3303 CARNEGIE AVE. Cleveland,  OH  44115
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-19
Decision Date1998-03-05
Summary:summary

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