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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 K001844
Device Name MODIFICATION TO CENTAUR SPINAL SYSTEM
Applicant
Howmedica Osteonics Corp.
59 Route 17 S.
Allendale,  NJ  07401 -1677
Applicant Contact MARY-CATHERINE DILLON
Correspondent
Howmedica Osteonics Corp.
59 Route 17 S.
Allendale,  NJ  07401 -1677
Correspondent Contact MARY-CATHERINE DILLON
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/19/2000
Decision Date 07/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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