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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 K041592
Device Name CORAL SPINAL SYSTEM
Applicant
Theken Surgical
283 E. Waterloo Rd.
Akron,  OH  44203
Applicant Contact RANDY THEKEN
Correspondent
Theken Surgical
283 E. Waterloo Rd.
Akron,  OH  44203
Correspondent Contact RANDY THEKEN
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH   MNI   NKB  
Date Received06/14/2004
Decision Date 09/16/2004
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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