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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 K052096
Device Name NUBIC SPINAL IMPLANT
Applicant
Signus Medical, LLC
4050 Olson Memorial Hwy.
Suite 350
Minneapolis,  MN  55422
Applicant Contact TRACY L GRAY
Correspondent
Signus Medical, LLC
4050 Olson Memorial Hwy.
Suite 350
Minneapolis,  MN  55422
Correspondent Contact TRACY L GRAY
Regulation Number888.3060
Classification Product Code
MQP  
Date Received08/03/2005
Decision Date 08/16/2005
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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