ANTERIOR DYNAMIZED 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 Anterior Dynamized System.

Pre-market Notification Details

Device IDK953978
510k NumberK953978
Device Name:ANTERIOR DYNAMIZED SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant ACROMED CORP. 3303 CARNEGIE AVE. Cleveland,  OH  44115
ContactGregory Cannedy
CorrespondentGregory Cannedy
ACROMED CORP. 3303 CARNEGIE AVE. Cleveland,  OH  44115
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-23
Decision Date1997-02-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034005362 K953978 000
10705034241470 K953978 000

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