ClearanceBrief
Company · US

SurGenTec, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.

33510(k) clearances (9 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
OURSacroiliac Joint Fixation8
FMFSyringe, Piston6
MRWSystem, Facet Screw Spinal Device6
MQVFiller, Bone Void, Calcium Compound5
OLOOrthopedic Stereotaxic Instrument3
KNWInstrument, Biopsy2
GZTRetractor, Self-Retaining, For Neurosurgery1
HRXArthroscope1
PDQNeurosurgical Nerve Locator1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 14, 2026K263208Vantage Lumbar Decompression Kit
SurGenTec, LLC
HRX
Sep 17, 2026K252995Durashield Device Kit
SurGenTec, LLC
GZT
Aug 26, 2026K262581GraftGun Universal Graft Delivery System (GDS®)
SurGenTec, LLC
FMF
Aug 24, 2026K261381TiLink-L™ SI Joint Fusion System
SurGenTec, LLC
OUR
Jul 24, 2026K262121Ion-L Navigated Instruments
SurGenTec, LLC
OLO
Jun 11, 2026K261209Ion-L
SurGenTec, LLC
MRW
May 22, 2026K260329Ion-C Navigation Instruments
SurGenTec, LLC
OLO
Mar 20, 2026K253604TiLink-L Navigation Instruments
SurGenTec, LLC
OLO
Jan 16, 2026K251714Ion-C
SurGenTec, LLC
MRW
Jul 2, 2025K251720OsteoFlo HydroFiber
SurGenTec, LLC
MQV
May 28, 2025K243949OsteoFlo HydroFiber
SurGenTec, LLC
MQV
Apr 24, 2025K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
SurGenTec, LLC
KNW
Feb 5, 2025K243580GraftGun Universal Graft Delivery System (GDS)
SurGenTec, LLC
FMF
Dec 27, 2024K243835TiLink-P SI Joint Fusion System
SurGenTec, LLC
OUR
Dec 23, 2024K242797OsteoFlo HydroFiber
SurGenTec, LLC
MQV
Dec 4, 2024K243265Ion 3D
SurGenTec, LLC
MRW
Nov 21, 2024K242414TiLink-P Joint Fusion System
SurGenTec, LLC
OUR
Aug 21, 2024K242141TiLink-P SI Joint Fusion System
SurGenTec, LLC
OUR
Aug 9, 2024K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
SurGenTec, LLC
KNW
Jun 17, 2024K241416Ion 3D
SurGenTec, LLC
MRW
Apr 11, 2024K240720TiLink-P SI Joint Fusion System
SurGenTec, LLC
OUR
Feb 8, 2024K240086Ion 3D
SurGenTec, LLC
MRW
Oct 2, 2023K231716OsteoFlo® HydroPutty™
SurGenTec, LLC
MQV
Sep 25, 2023K230857TiLink-P SI Joint Fusion System
SurGenTec, LLC
OUR
Aug 3, 2023K231831TiLink-L Joint Fusion System
Surgentec
OUR
Jun 7, 2023K230446TiLink-L SI Joint Fusion System
SurGenTec, LLC
OUR
Feb 25, 2022K211855Ion Facet Screw System
SurGenTec, LLC
MRW
Sep 3, 2020K2019003D GraftRasp System
Surgentec
FMF
Aug 14, 2020K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft
SurGenTec, LLC
MQV
May 18, 2020K2004313D GraftRasp System
Surgentec
FMF
Jul 16, 2019K190163ALARA Neuro Access Kit
SurGenTec, LLC
PDQ
May 10, 2018K180937Graftgun Universal Graft Delivery System
SurGenTec, LLC
FMF
Jul 19, 2017K170675Graftgun Universal Graft Delivery System
SurGenTec, LLC
FMF

Latest recalls

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