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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K041625
Device Name LTD POLYAXIAL FIXATION SYSTEM
Applicant
U.S. SPINAL TECHNOLOGIES, LLC.
PO BOX 560
STILL WATER,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
U.S. SPINAL TECHNOLOGIES, LLC.
PO BOX 560
STILL WATER,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received06/15/2004
Decision Date 09/08/2004
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
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