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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 K031757
Device Name PEEK TETRIS SPINAL IMPLANT
Applicant
Signus Medical, LLC
4050 Olson Memorial Hwy.
Suite 350
Minneapolis,  MN  55422
Applicant Contact AL ALEXANDER
Correspondent
Signus Medical, LLC
4050 Olson Memorial Hwy.
Suite 350
Minneapolis,  MN  55422
Correspondent Contact AL ALEXANDER
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/06/2003
Decision Date 07/30/2003
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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