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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
Recalls CDRH Recalls
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