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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 K032064
Device Name THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM
Applicant
Theken Surgical,Llc
283 E. Waterloo Rd.
Akron,  OH  44319
Applicant Contact TONY PERRY
Correspondent
Theken Surgical,Llc
283 E. Waterloo Rd.
Akron,  OH  44319
Correspondent Contact TONY PERRY
Regulation Number888.3060
Classification Product Code
MQP  
Date Received07/03/2003
Decision Date 02/20/2004
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
Recalls CDRH Recalls
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