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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K181139
Device Name OLYMPIC Posterior Spinal Fixation System
Applicant
Astura Medical, LLC
3168 Lionshead Ave., Suite 100
Carlsbad,  CA  92010
Applicant Contact Parker Kelch
Correspondent
Astura Medical, LLC
3168 Lionshead Ave., Suite 100
Carlsbad,  CA  92010
Correspondent Contact Parker Kelch
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received04/30/2018
Decision Date 07/06/2018
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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