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SurGenTec, LLC

FDA 510(k) & PMA Approved Devices — 26 products

Total Devices26
Categories7
Latest FDA decision2026-07-24
TypeNumberDevice NameCodeDateActions
510(k) K262121 Ion-L Navigated InstrumentsOLO2026-07-24 View
510(k) K261209 Ion-LMRW2026-06-11 View
510(k) K260329 Ion-C Navigation InstrumentsOLO2026-05-22 View
510(k) K253604 TiLink-L Navigation InstrumentsOLO2026-03-20 View
510(k) K251714 Ion-CMRW2026-01-16 View
510(k) K251720 OsteoFlo HydroFiberMQV2025-07-02 View
510(k) K243949 OsteoFlo HydroFiberMQV2025-05-28 View
510(k) K243945 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNW2025-04-24 View
510(k) K243580 GraftGun Universal Graft Delivery System (GDS)FMF2025-02-05 View
510(k) K243835 TiLink-P SI Joint Fusion SystemOUR2024-12-27 View
510(k) K242797 OsteoFlo HydroFiberMQV2024-12-23 View
510(k) K243265 Ion 3DMRW2024-12-04 View
510(k) K242414 TiLink-P Joint Fusion SystemOUR2024-11-21 View
510(k) K242141 TiLink-P SI Joint Fusion SystemOUR2024-08-21 View
510(k) K240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNW2024-08-09 View
510(k) K241416 Ion 3DMRW2024-06-17 View
510(k) K240720 TiLink-P SI Joint Fusion SystemOUR2024-04-11 View
510(k) K240086 Ion 3DMRW2024-02-08 View
510(k) K231716 OsteoFlo® HydroPutty™MQV2023-10-02 View
510(k) K230857 TiLink-P SI Joint Fusion SystemOUR2023-09-25 View

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