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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 K922238
Device Name LEAPLAZA FRAME
Applicant
Spintech, Inc.
982 E. Hennepin Ave.
Minneapolis,  MN  55414
Applicant Contact RICHARD D JENSEN
Correspondent
Spintech, Inc.
982 E. Hennepin Ave.
Minneapolis,  MN  55414
Correspondent Contact RICHARD D JENSEN
Regulation Number888.3050
Classification Product Code
KWP  
Date Received05/13/1992
Decision Date 12/23/1992
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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