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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 K875290
Device Name LUMBAR IMPACTION SET
Applicant
T. Korossurgical Instruments Corp.
610 Flinn Ave.
Moorepark,  CA  93021
Applicant Contact TIBOR KOROS
Correspondent
T. Korossurgical Instruments Corp.
610 Flinn Ave.
Moorepark,  CA  93021
Correspondent Contact TIBOR KOROS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received12/30/1987
Decision Date 03/04/1988
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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