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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 Interlaminal
510(k) Number K850039
Device Name HALIFAX SPINAL CLAMP
Applicant
Levtech, Inc.
P.O. Box 516
Jacksonville,  FL  32201
Applicant Contact PENTECOST
Correspondent
Levtech, Inc.
P.O. Box 516
Jacksonville,  FL  32201
Correspondent Contact PENTECOST
Regulation Number888.3050
Classification Product Code
KWP  
Date Received01/07/1985
Decision Date 05/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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