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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 K070786
Device Name X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
Applicant
THEKEN SPINE LLC
283 E WATERLOO RD.
AKRON,  OH  44319
Applicant Contact DALE DAVISON
Correspondent
THEKEN SPINE LLC
283 E WATERLOO RD.
AKRON,  OH  44319
Correspondent Contact DALE DAVISON
Regulation Number888.3060
Classification Product Code
MQP  
Date Received03/22/2007
Decision Date 06/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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