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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K211855
FOIA Releasable 510(k) K211855
Device Name Ion Facet Screw System
Applicant
SurGenTec, LLC
911 Clint Moore Rd.
Boca Raton,  FL  33487
Applicant Contact Andrew Shoup
Correspondent
SurGenTec, LLC
911 Clint Moore Rd.
Boca Raton,  FL  33487
Correspondent Contact Andrew Shoup
Classification Product Code
MRW  
Date Received06/16/2021
Decision Date 02/25/2022
Decision Substantially Equivalent (SESE)
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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