Medical Device Manufacturer · US , Boca Raton , FL

SurGenTec, LLC

22 submissions · 22 cleared · Since 2017
22
Total
22
Cleared
0
Denied

SurGenTec, LLC — FDA 510(k) Submissions

SurGenTec, LLC has submitted 22 FDA 510(k) premarket notifications since 2017, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Sacroiliac Joint Fixation, Filler, Bone Void, Calcium Compound, System, Facet Screw Spinal Device, Syringe, Piston, Instrument, Biopsy . Use the specialty filter in the sidebar to narrow results.

22 devices
1–22 of 22
Ion-C
K251714 · MRW System, Facet Screw... · Orthopedic
Jan 2026 227d
OsteoFlo HydroFiber
K251720 · MQV Filler, Bone Void,... · Orthopedic
Jul 2025 28d
OsteoFlo HydroFiber
K243949 · MQV Filler, Bone Void,... · Orthopedic
May 2025 156d
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
K243945 · KNW Instrument, Biopsy · General & Plastic Surgery
Apr 2025 125d
GraftGun Universal Graft Delivery System (GDS)
K243580 · FMF Syringe, Piston · Orthopedic
Feb 2025 78d
TiLink-P SI Joint Fusion System
K243835 · OUR Sacroiliac Joint Fixation · Orthopedic
Dec 2024 14d
OsteoFlo HydroFiber
K242797 · MQV Filler, Bone Void,... · Orthopedic
Dec 2024 98d
Ion 3D
K243265 · MRW System, Facet Screw... · Orthopedic
Dec 2024 50d
TiLink-P Joint Fusion System
K242414 · OUR Sacroiliac Joint Fixation · Orthopedic
Nov 2024 99d
TiLink-P SI Joint Fusion System
K242141 · OUR Sacroiliac Joint Fixation · Orthopedic
Aug 2024 30d
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
K240664 · KNW Instrument, Biopsy · General & Plastic Surgery
Aug 2024 154d
Ion 3D
K241416 · MRW System, Facet Screw... · Orthopedic
Jun 2024 31d
TiLink-P SI Joint Fusion System
K240720 · OUR Sacroiliac Joint Fixation · Orthopedic
Apr 2024 27d
Ion 3D
K240086 · MRW System, Facet Screw... · Orthopedic
Feb 2024 28d
OsteoFlo? HydroPutty?
K231716 · MQV Filler, Bone Void,... · Orthopedic
Oct 2023 111d
TiLink-P SI Joint Fusion System
K230857 · OUR Sacroiliac Joint Fixation · Orthopedic
Sep 2023 180d
TiLink-L SI Joint Fusion System
K230446 · OUR Sacroiliac Joint Fixation · Orthopedic
Jun 2023 106d
Ion Facet Screw System
K211855 · MRW System, Facet Screw... · Orthopedic
Feb 2022 254d
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft
K200064 · MQV Filler, Bone Void,... · Orthopedic
Aug 2020 214d
ALARA Neuro Access Kit
K190163 · PDQ Neurosurgical Nerve Locator · Neurology
Jul 2019 166d
Graftgun Universal Graft Delivery System
K180937 · FMF Syringe, Piston · General Hospital
May 2018 30d
Graftgun Universal Graft Delivery System
K170675 · FMF Syringe, Piston · General Hospital
Jul 2017 135d
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