SurGenTec, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
25
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251714Ion-CJanuary 16, 2026
K251720OsteoFlo HydroFiberJuly 2, 2025
K243949OsteoFlo HydroFiberMay 28, 2025
K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)April 24, 2025
K243580GraftGun Universal Graft Delivery System (GDS)February 5, 2025
K243835TiLink-P SI Joint Fusion SystemDecember 27, 2024
K242797OsteoFlo HydroFiberDecember 23, 2024
K243265Ion 3DDecember 4, 2024
K242414TiLink-P Joint Fusion SystemNovember 21, 2024
K242141TiLink-P SI Joint Fusion SystemAugust 21, 2024
K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)August 9, 2024
K241416Ion 3DJune 17, 2024
K240720TiLink-P SI Joint Fusion SystemApril 11, 2024
K240086Ion 3DFebruary 8, 2024
K231716OsteoFlo® HydroPutty™October 2, 2023
K230857TiLink-P SI Joint Fusion SystemSeptember 25, 2023
K231831TiLink-L Joint Fusion SystemAugust 3, 2023
K230446TiLink-L SI Joint Fusion SystemJune 7, 2023
K211855Ion Facet Screw SystemFebruary 25, 2022
K2019003D GraftRasp SystemSeptember 3, 2020