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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K993030
Device Name MODIFICATION TO ISOLA SPINAL SYSTEM
Applicant
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767 -0350
Applicant Contact FRANK MAAS
Correspondent
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767 -0350
Correspondent Contact FRANK MAAS
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received09/07/1999
Decision Date 12/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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