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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

SurGenTec, LLC — Predicate Candidate Screening

26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

106 daysmedian FDA review time
214 days90th percentile
26clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K262121Ion-L Navigated InstrumentsSurGenTec, LLC2026-07-24310
K261209Ion-LSurGenTec, LLC2026-06-11590
K260329Ion-C Navigation InstrumentsSurGenTec, LLC2026-05-221120
K253604TiLink-L Navigation InstrumentsSurGenTec, LLC2026-03-201220
K251714Ion-CSurGenTec, LLC2026-01-162270
K251720OsteoFlo HydroFiberSurGenTec, LLC2025-07-02280
K243949OsteoFlo HydroFiberSurGenTec, LLC2025-05-281560
K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC2025-04-241250
K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC2025-02-05780
K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC2024-12-27140
K242797OsteoFlo HydroFiberSurGenTec, LLC2024-12-23980
K243265Ion 3DSurGenTec, LLC2024-12-04500
K242414TiLink-P Joint Fusion SystemSurGenTec, LLC2024-11-21990
K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC2024-08-21300
K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC2024-08-091540
K241416Ion 3DSurGenTec, LLC2024-06-17310
K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC2024-04-11270
K240086Ion 3DSurGenTec, LLC2024-02-08280
K231716OsteoFlo® HydroPutty™SurGenTec, LLC2023-10-021110
K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC2023-09-251800
K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC2023-06-071060
K211855Ion Facet Screw SystemSurGenTec, LLC2022-02-252540
K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC2020-08-142140
K190163ALARA Neuro Access KitSurGenTec, LLC2019-07-161660
K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC2018-05-10300
K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC2017-07-191350

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda