Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

SurGenTec, LLC

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories7
Latest Approval2026-03-20
TypeNumberDevice NameCodeDate
510(k) K253604 TiLink-L Navigation Instruments OLO 2026-03-20 View
510(k) K251714 Ion-C MRW 2026-01-16 View
510(k) K251720 OsteoFlo HydroFiber MQV 2025-07-02 View
510(k) K243949 OsteoFlo HydroFiber MQV 2025-05-28 View
510(k) K243945 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) KNW 2025-04-24 View
510(k) K243580 GraftGun Universal Graft Delivery System (GDS) FMF 2025-02-05 View
510(k) K243835 TiLink-P SI Joint Fusion System OUR 2024-12-27 View
510(k) K242797 OsteoFlo HydroFiber MQV 2024-12-23 View
510(k) K243265 Ion 3D MRW 2024-12-04 View
510(k) K242414 TiLink-P Joint Fusion System OUR 2024-11-21 View
510(k) K242141 TiLink-P SI Joint Fusion System OUR 2024-08-21 View
510(k) K240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) KNW 2024-08-09 View
510(k) K241416 Ion 3D MRW 2024-06-17 View
510(k) K240720 TiLink-P SI Joint Fusion System OUR 2024-04-11 View
510(k) K240086 Ion 3D MRW 2024-02-08 View
510(k) K231716 OsteoFlo® HydroPutty™ MQV 2023-10-02 View
510(k) K230857 TiLink-P SI Joint Fusion System OUR 2023-09-25 View
510(k) K230446 TiLink-L SI Joint Fusion System OUR 2023-06-07 View
510(k) K211855 Ion Facet Screw System MRW 2022-02-25 View
510(k) K200064 OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft MQV 2020-08-14 View

Page 1 of 2

↑