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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 K220324
Device Name AccuFit Lateral 2-Hole Plate
Applicant
Precision Spine, Inc.
2050 Executive Dr..
Pear,  MS  39208
Applicant Contact Michael Dawson
Correspondent
Element Materials Technology
3701 Port Union Rd.
Fairfield,  OH  45014
Correspondent Contact Lisa Ferrara
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/03/2022
Decision Date 03/16/2022
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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