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Data / Medical devices / United States / Surgentec LLC

Surgentec LLC: FDA-registered device maker in Boca Raton, FL, United States, 36 510(k) clearances

Surgentec LLC is registered with the FDA (registration 3012495575) in Boca Raton, FL, United States. It lists 17 device types. The FDA files 36 510(k) clearances under its listings, the newest dated October 14, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Surgentec LLC
FDA registration number
3012495575
Address
911 Clint Moore Rd, Boca Raton, FL, United States, 33487
Owner or operator
SurGenTec LLC (10055452)
Roles
Manufacturer
First device listed
July 31, 2017
Registered through
2027
Brand names listed
3D GraftRasp System, ALARA Access Needle, ALARA BMA Neuro Access, ALARA BMA Neuro Access Kit, ALARA BMAN, ALARA BMAN ACCESS, ALARA Neuro Access Kit, Assorted Adapter Tips and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Manufactureraccessdata.fda.gov
ArthroscopeHRX2Manufactureraccessdata.fda.gov
Cover, Barrier, ProtectiveMMP2Manufactureraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Manufactureraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Manufactureraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Manufactureraccessdata.fda.gov
Instrument, BiopsyKNW2Manufactureraccessdata.fda.gov
Neurosurgical Nerve LocatorPDQ2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Manufactureraccessdata.fda.gov
RaspHTR1Manufactureraccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Manufactureraccessdata.fda.gov
Ring (Wound Protector), Drape Retention, InternalKGW2Manufactureraccessdata.fda.gov
Rongeur, ManualHAE2Manufactureraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Manufactureraccessdata.fda.gov
Syringe, PistonFMF2Manufactureraccessdata.fda.gov
System, Facet Screw Spinal DeviceMRWUManufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 14, 2026K263208Vantage Lumbar Decompression KitHRXSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
September 17, 2026K252995Durashield Device KitGZTSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
August 26, 2026K262581GraftGun Universal Graft Delivery System (GDS®)FMFSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
August 24, 2026K261381TiLink-L™ SI Joint Fusion SystemOURSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
July 24, 2026K262121Ion-L Navigated InstrumentsOLOSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
June 11, 2026K261209Ion-LMRWSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
May 22, 2026K260329Ion-C Navigation InstrumentsOLOSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
March 20, 2026K253604TiLink-L Navigation InstrumentsOLOSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
March 12, 2026K252546VantageTM Lumbar Decompression KitHRXSubstantially EquivalentAllevion Medical, LLCaccessdata.fda.gov
January 16, 2026K251714Ion-CMRWSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
July 2, 2025K251720OsteoFlo HydroFiberMQVSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
May 28, 2025K243949OsteoFlo HydroFiberMQVSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
April 24, 2025K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNWSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
February 5, 2025K243580GraftGun Universal Graft Delivery System (GDS)FMFSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
December 27, 2024K243835TiLink-P SI Joint Fusion SystemOURSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
December 23, 2024K242797OsteoFlo HydroFiberMQVSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
December 4, 2024K243265Ion 3DMRWSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
November 21, 2024K242414TiLink-P Joint Fusion SystemOURSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
August 21, 2024K242141TiLink-P SI Joint Fusion SystemOURSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
August 9, 2024K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNWSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
June 17, 2024K241416Ion 3DMRWSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
April 11, 2024K240720TiLink-P SI Joint Fusion SystemOURSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
February 8, 2024K240086Ion 3DMRWSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
October 2, 2023K231716OsteoFlo® HydroPutty™MQVSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
September 25, 2023K230857TiLink-P SI Joint Fusion SystemOURSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
August 3, 2023K231831TiLink-L Joint Fusion SystemOURSubstantially EquivalentSurgentecaccessdata.fda.gov
June 7, 2023K230446TiLink-L SI Joint Fusion SystemOURSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
February 25, 2022K211855Ion Facet Screw SystemMRWSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
September 3, 2020K2019003D GraftRasp SystemFMFSubstantially EquivalentSurgentecaccessdata.fda.gov
August 14, 2020K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftMQVSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
May 18, 2020K2004313D GraftRasp SystemFMFSubstantially EquivalentSurgentecaccessdata.fda.gov
July 16, 2019K190163ALARA Neuro Access KitPDQSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
May 10, 2018K180937Graftgun Universal Graft Delivery SystemFMFSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
July 19, 2017K170675Graftgun Universal Graft Delivery SystemFMFSubstantially EquivalentSurGenTec, LLCaccessdata.fda.gov
March 23, 2011K110367PIONEER SPINAL PROCESS FUSION PLATEKWPSubstantially EquivalentPioneer Surgical Technology, Inc.accessdata.fda.gov
October 22, 2010K101525PIONEER SPINOUS PROCESS FUSION PLATEKWPSubstantially EquivalentPioneer Surgical Technologyaccessdata.fda.gov

Compare with other makers

Updated October 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.