FDA.report

SURGENTEC LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30124955753012495575SURGENTEC LLC1N2026-01-01911 Clint Moore Rd Boca Raton FL US 33487

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2099191698437825K253604TiLink-L Navigation InstrumentsOLO2026-03-20
2099191641053026K251720OsteoFlo HydroFiberMQV2025-07-02
2099191398606163K251714Ion-CMRW2026-01-16
2099191825049498K243949OsteoFlo HydroFiberMQV2025-05-28
2099191852359408K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNW2025-04-24
2099191680970598K243835TiLink-P SI Joint Fusion SystemOUR2024-12-27
2099191590151196K243580GraftGun Universal Graft Delivery System (GDS)FMF2025-02-05
2099191382224612K243265Ion 3DMRW2024-12-04
2099191908085480K242797OsteoFlo HydroFiberMQV2024-12-23
2099191111255155K242414TiLink-P Joint Fusion SystemOUR2024-11-21
2099191467674049K242141TiLink-P SI Joint Fusion SystemOUR2024-08-21
2099191292862518K241416Ion 3DMRW2024-06-17
2099191997113744K240720TiLink-P SI Joint Fusion SystemOUR2024-04-11
2099191156560608K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNW2024-08-09
2099191023326249K240086Ion 3DMRW2024-02-08
2099191839120089K231831TiLink-L Joint Fusion SystemOUR2023-08-03
2099191873439868K231716OsteoFlo® HydroPutty™MQV2023-10-02
2099191224257326K230857TiLink-P SI Joint Fusion SystemOUR2023-09-25
2099191491815926K230446TiLink-L SI Joint Fusion SystemOUR2023-06-07
2099191775727545K211855Ion Facet Screw SystemMRW2022-02-25
2099191869578156K2019003D GraftRasp SystemFMF2020-09-03
2099191563080576K2004313D GraftRasp SystemFMF2020-05-18
2099191365885352K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftMQV2020-08-14
2099191328781202K190163ALARA Neuro Access KitPDQ2019-07-16
2099191622529795K180937Graftgun Universal Graft Delivery SystemFMF2018-05-10
2099191704918884K170675Graftgun Universal Graft Delivery SystemFMF2017-07-19
2099191134473795K110367PIONEER SPINAL PROCESS FUSION PLATEKWP2011-03-23
2099191258615464K101525PIONEER SPINOUS PROCESS FUSION PLATEKWP2010-10-22
2099191659790508
2099191665384739

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
OUR72024-12-27
MRW52026-01-16
MQV52025-07-02
FMF52025-02-05
KNW22025-04-24
KWP22011-03-23
OLO12026-03-20
PDQ12019-07-16

PMN

Ion 3D

2024-12-04

SurGenTec, LLC

Ion 3D

2024-06-17

SurGenTec, LLC

Ion 3D

2024-02-08

SurGenTec, LLC

GUDID

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