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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 K211932
Device Name Fixxsure Anterior Lumbar Plate and Screw System
Applicant
Oak Tree Engineering, LLC
419 Main St., #242,
Huntington Beach,  CA  92648
Applicant Contact Douglas W Neary
Correspondent
Consultant
419 Main St., #242,
Huntington Beach,  CA  92648
Correspondent Contact Douglas w Neary
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/22/2021
Decision Date 07/27/2021
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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