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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 K041888
Device Name CURVED PEEK TETRIS SPINAL IMPLANT
Applicant
Signus Medizintechnik GmbH
5050 Olson Memorial Hwy.
Suite 350
Minneapolis,  MN  55422
Applicant Contact TRACY L GRAY
Correspondent
Signus Medizintechnik GmbH
5050 Olson Memorial Hwy.
Suite 350
Minneapolis,  MN  55422
Correspondent Contact TRACY L GRAY
Regulation Number888.3060
Classification Product Code
MQP  
Date Received07/12/2004
Decision Date 08/10/2004
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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