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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 K884690
Device Name KIRSCHNER SPINAL FIXATOR KMS-1
Applicant
Kirschner Medical Corp.
9690 Deereco Rd.D
Timonium,  MD  21093
Applicant Contact SAM SON
Correspondent
Kirschner Medical Corp.
9690 Deereco Rd.D
Timonium,  MD  21093
Correspondent Contact SAM SON
Regulation Number888.3050
Classification Product Code
KWP  
Date Received11/09/1988
Decision Date 06/02/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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