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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K192006
Device Name SIRION Lateral Lumbar Interbody 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 Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
KWQ   OVD  
Date Received07/29/2019
Decision Date 04/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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