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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K901144
Device Name LEVTECH BONE SCREW
Applicant
Levtech, Inc.
P.O. Box 516
Jacksonville,  FL  32201
Applicant Contact LEVON PENTECOST
Correspondent
Levtech, Inc.
P.O. Box 516
Jacksonville,  FL  32201
Correspondent Contact LEVON PENTECOST
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/12/1990
Decision Date 10/10/1990
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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