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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 K041798
Device Name ATALIA TITANIUM SURGICAL MESH
Applicant
Us Spinal Technologies, LLC
P.O. Box 560
Stillwater,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
Us Spinal Technologies, LLC
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number888.3060
Classification Product Code
MQP  
Date Received07/02/2004
Decision Date 02/07/2005
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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