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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 K201079
Device Name Aurora® Anterior Lumbar Plate Sytstem
Applicant
Prism Surgical Design Pty Ltd.
15/43 Lang Parade
Milton,  AU 4064
Applicant Contact Emma May Young
Correspondent
Empirical Testing Corp.
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/22/2020
Decision Date 08/05/2020
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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