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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 K992792
Device Name XIA SPINAL SYSTEM C-C ADAPTOR
Applicant
Howmedica Osteonics Corp.
59 Rte. 17 S.
Allendale,  NJ  07401
Applicant Contact KAREN ARIEMMA
Correspondent
Howmedica Osteonics Corp.
59 Rte. 17 S.
Allendale,  NJ  07401
Correspondent Contact KAREN ARIEMMA
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received08/19/1999
Decision Date 11/16/1999
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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