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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K081332
Device Name ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM
Applicant
Signus Medizintechnik GmbH
8202 Sherman Rd.
Chesterland,  OH  44026
Applicant Contact KAREN E WARDEN
Correspondent
Signus Medizintechnik GmbH
8202 Sherman Rd.
Chesterland,  OH  44026
Correspondent Contact KAREN E WARDEN
Regulation Number888.3060
Classification Product Code
MQP  
Date Received05/12/2008
Decision Date 06/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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