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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 K001319
Device Name XIA SPINE SYSTEM HOOKS
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 Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWQ   MNI  
Date Received04/26/2000
Decision Date 05/23/2000
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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