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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K062348
Device Name TIMESH SELF DRILLING SCREW
Applicant
Medtronic Neurosurgery
125 Cremona Dr.
Goleta,  CA  93117
Applicant Contact JEFFREY HENDERSON
Correspondent
Medtronic Neurosurgery
125 Cremona Dr.
Goleta,  CA  93117
Correspondent Contact JEFFREY HENDERSON
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received08/11/2006
Decision Date 09/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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