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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 K060416
Device Name OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
Applicant
Ulrich GmbH & Co. KG
2519 Mcmullen Booth Rd.
Suite 510-295
Clearwater,  FL  33759
Applicant Contact IAN P GORDON
Correspondent
Ulrich GmbH & Co. KG
2519 Mcmullen Booth Rd.
Suite 510-295
Clearwater,  FL  33759
Correspondent Contact IAN P GORDON
Regulation Number888.3060
Classification Product Code
MQP  
Date Received02/17/2006
Decision Date 12/26/2006
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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