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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K980852
Device Name GII SPINAL FIXATION SYSTEM
Applicant
Karen E. Warden, M.E.B.E.
2249 Elm St., Suite 501
Cleveland,  OH  44113
Applicant Contact KAREN E WARDEN
Correspondent
Karen E. Warden, M.E.B.E.
2249 Elm St., Suite 501
Cleveland,  OH  44113
Correspondent Contact KAREN E WARDEN
Regulation Number888.3070
Classification Product Code
MNH  
Date Received03/05/1998
Decision Date 05/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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