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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K944737
Device Name ISOLA SPINE SYSTEM
Applicant
Acromed Corp.
3303 Carnegie Ave.
Cleveland,  OH  44115
Applicant Contact JOYCE THOMS
Correspondent
Acromed Corp.
3303 Carnegie Ave.
Cleveland,  OH  44115
Correspondent Contact JOYCE THOMS
Regulation Number888.3070
Classification Product Code
MNH  
Date Received09/26/1994
Decision Date 06/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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