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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 K261209
Device Name Ion-L
Applicant
SurGenTec, LLC
911 Clint Moore
Boca Raton,  FL  33487
Applicant Contact Richard Sharp
Correspondent
SurGenTec, LLC
911 Clint Moore Road
Boca Raton,  FL  33487
Correspondent Contact Guilherme Pires
Classification Product Code
MRW  
Date Received04/13/2026
Decision Date 06/11/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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