Chrysalis Intelligence · Sponsors · SurGenTec, LLC

SurGenTec, LLC

Boca Raton, FL, US · 29 510(k) clearances

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Total clearances
29
2020-05-18 → 2026-09-17
Last 12 months
8
Product codes
7
Most recent
2026-09-17
Name variants in FDA filings: SurGenTec, LLC / Surgentec
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OUR Sacroiliac Joint Fixation Class II Orthopedic 8 2026-08-24
MRW System, Facet Screw Spinal Device Unclassified Unknown 6 2026-06-11
MQV Filler, Bone Void, Calcium Compound Class II Orthopedic 5 2025-07-02
FMF Syringe, Piston Class II General Hospital 4 2026-08-26
OLO Orthopedic Stereotaxic Instrument Class II Neurology 3 2026-07-24
KNW Instrument, Biopsy Class II Gastroenterology, Urology 2 2025-04-24
GZT Retractor, Self-Retaining, For Neurosurgery Class II Neurology 1 2026-09-17
Filings

All 510(k) clearances (29)

Date K-number Device Code Class Specialty
2026-09-17 K252995 Durashield Device Kit GZT Class II Neurology
2026-08-26 K262581 GraftGun Universal Graft Delivery System (GDS®) FMF Class II General Hospital
2026-08-24 K261381 TiLink-L™ SI Joint Fusion System OUR Class II Orthopedic
2026-07-24 K262121 Ion-L Navigated Instruments OLO Class II Neurology
2026-06-11 K261209 Ion-L MRW Unclassified Unknown
2026-05-22 K260329 Ion-C Navigation Instruments OLO Class II Neurology
2026-03-20 K253604 TiLink-L Navigation Instruments OLO Class II Neurology
2026-01-16 K251714 Ion-C MRW Unclassified Unknown
2025-07-02 K251720 OsteoFlo HydroFiber MQV Class II Orthopedic
2025-05-28 K243949 OsteoFlo HydroFiber MQV Class II Orthopedic
2025-04-24 K243945 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) KNW Class II Gastroenterology, Urology
2025-02-05 K243580 GraftGun Universal Graft Delivery System (GDS) FMF Class II General Hospital
2024-12-27 K243835 TiLink-P SI Joint Fusion System OUR Class II Orthopedic
2024-12-23 K242797 OsteoFlo HydroFiber MQV Class II Orthopedic
2024-12-04 K243265 Ion 3D MRW Unclassified Unknown
2024-11-21 K242414 TiLink-P Joint Fusion System OUR Class II Orthopedic
2024-08-21 K242141 TiLink-P SI Joint Fusion System OUR Class II Orthopedic
2024-08-09 K240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) KNW Class II Gastroenterology, Urology
2024-06-17 K241416 Ion 3D MRW Unclassified Unknown
2024-04-11 K240720 TiLink-P SI Joint Fusion System OUR Class II Orthopedic
2024-02-08 K240086 Ion 3D MRW Unclassified Unknown
2023-10-02 K231716 OsteoFlo® HydroPutty™ MQV Class II Orthopedic
2023-09-25 K230857 TiLink-P SI Joint Fusion System OUR Class II Orthopedic
2023-08-03 K231831 TiLink-L Joint Fusion System OUR Class II Orthopedic
2023-06-07 K230446 TiLink-L SI Joint Fusion System OUR Class II Orthopedic
2022-02-25 K211855 Ion Facet Screw System MRW Unclassified Unknown
2020-09-03 K201900 3D GraftRasp System FMF Class II General Hospital
2020-08-14 K200064 OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft MQV Class II Orthopedic
2020-05-18 K200431 3D GraftRasp System FMF Class II General Hospital
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence