KANEDA SR ANTERIOR SPINAL SYSTEM

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 Sr Anterior Spinal System.

Pre-market Notification Details

Device IDK971248
510k NumberK971248
Device Name:KANEDA SR ANTERIOR SPINAL SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant ACROMED CORP. 3303 CARNEGIE AVE. Cleveland,  OH  44115
ContactWilliam Christianson
CorrespondentWilliam Christianson
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 Received1997-04-03
Decision Date1997-06-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034241319 K971248 000

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