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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K990158
Device Name OSTEONICS COMBINATION SCREW RING/BLOCKER
Applicant
Osteonics Corp.
59 Rte. 17
Allendale,  NJ  07401
Applicant Contact KATE SUTTON
Correspondent
Osteonics Corp.
59 Rte. 17
Allendale,  NJ  07401
Correspondent Contact KATE SUTTON
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received01/19/1999
Decision Date 02/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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