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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 K990959
Device Name K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
Applicant
SPINEOLOGY, INC.
1815 NORTHWESTERN AVE.
STILLWATER,  MN  55082
Applicant Contact PAMELA SNYDER
Correspondent
SPINEOLOGY, INC.
1815 NORTHWESTERN AVE.
STILLWATER,  MN  55082
Correspondent Contact PAMELA SNYDER
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/22/1999
Decision Date 12/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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