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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 K251714
Device Name Ion-C
Applicant
SurGenTec, LLC
911 Clint Moore Rd.
Boca Raton,  FL  33487
Applicant Contact Guilherme Pires
Correspondent
SurGenTec, LLC
911 Clint Moore Rd.
Boca Raton,  FL  33487
Correspondent Contact Guilherme Pires
Classification Product Code
MRW  
Date Received06/03/2025
Decision Date 01/16/2026
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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