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LUMITEX, INC.

US

Last updated May 23, 2026

Information

Country
US
Address
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
108631797

Catalogue (124)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
Seaspine Orthopedics Retractor Illuminator 009133
FDA UDI
Class IActive
Spinal Elements Adapter - Olympus 012016
FDA UDI
Class IActive
Pinnacle Spine Products 4mm ACMI Reusable Light Cable 009407
FDA UDI
Class IActive
CoreLink Bifurcated Illuminator 011929
FDA UDI
Class IActive
Lumitex Surgical Light Cable 005365
FDA UDI
Class IUnknown
Spinal Elements 26mm Port Illuminator 011020
FDA UDI
Class IActive
Thompson Surgical Instruments Large Lightmat 75mm 012529
FDA UDI
Class IActive
Alphatec Spine Storz Cable Adaptor 73554
FDA UDI
Class IActive
Globus Medical MARS Port Illuminator - 26mm 010541
EUDAMEDFDA UDI
Class IActive
Bones and Nerves Surgical Solutions Disposable Bifurcated Surgical Illuminator BNS-LT 10 02-S
FDA UDI
Class IActive
Lumitex Surgical Light Cable 006423
FDA UDI
Class IUnknown
STARlite Surgical Illuminator 5-pack 010166
FDA UDI
Class IUnknown
Spinal Elements 22mm Port Illuminator 011019
FDA UDI
Class IActive
Bones and Nerves 3.75mm Reusable Fiber Optic Cable BNS-LT 10 03-N
FDA UDI
Class IActive
Alphatec Spine Wolf Cable Adaptor 73551
FDA UDI
Class IActive
Triton Medical Port Illuminator 011939
FDA UDI
Class IActive
SeaSpine WOLF Cable Adapter 007977
FDA UDI
Class IActive
Zimmer Biomet - AccuVision Blade 25mm Flat Illuminated 007102
FDA UDI
Class IUnknown
Astura Bifurcated Surgical Illuminator 012126
FDA UDI
Class IActive
Spineart Storz Cable Adaptor MIS-IN 44 50-N
FDA UDI
Class IActive
Medacta International Adapter - ACMI 011204
FDA UDI
Class IActive
SeaSpine Surgical Illuminator Cable 008329
FDA UDI
Class IActive
Precision Spine Surgical Illuminator 011024
FDA UDI
Class IActive
Lumitex 3.5mm Fiber Optic Cable 012004
FDA UDI
Class IActive
Alphatec Spine Illico Directional Illuminator 008559
FDA UDI
Class IActive
In'Tech Medical 30mm Surgical Illuminator 009568
EUDAMEDFDA UDI
Class IActive
Spinal Elements PL Retractor Light 012656
FDA UDI
Class IActive
Spinal Elements Adapter - ACMI 012014
FDA UDI
Class IActive
K2M Reusable Light Cable - 4mm Universal/ACMI 011901
FDA UDI
Class IActive
Bilisoft 2.0 009766
FDA UDI
Class IIActive
Life Instrument Life Light Surgical Illuminator 703-0301-0
EUDAMEDFDA UDI
Class IActive
Viseon Spine Bifurcated Light Guide 012092
FDA UDI
Class IUnknown
Orthofix Pro-View Minimal Access Portal System 70-2304
FDA UDI
Class IActive
Alphatec Spine Battalion LLIF Light Cable 011043
FDA UDI
Class IUnknown
SeaSpine Orthopedics MIS Retractor Illuminator, Disposable 012214
FDA UDI
Class IActive
Spinal Elements Fiber Optic Cable 012013
FDA UDI
Class IUnknown
DePuy TSS Retractor Light Strip 5-Pack 012512
FDA UDI
Class IActive
4WEB Medical OA51S Surgical Illuminator 4WEB-OA51S-LC
FDA UDI
Class IActive
Fiber Optic Cable 005776
FDA UDI
Class IUnknown
MiRus Bifurcated Illuminator 17-518
FDA UDI
Class IActive
CoreLink 2.8mm ACMI Reusable Light Cable 009764
FDA UDI
Class IActive
Lumitex Medical Devices Adapter - STORZ 012142
FDA UDI
Class IActive
Spineart 2.5mm Universal Reusable Light Cable 008653
FDA UDI
Class IActive
Lumitex 4mm Universal Fiber Optic Cable 012139
FDA UDI
Class IActive
Thompson Surgical Instruments Small Lightmat 25mm 012511
FDA UDI
Class IActive
Alphatec Spine ACMI Cable Adaptor 73553
FDA UDI
Class IActive
Boss Instruments LightMat Surgical Illuminator 012118
FDA UDI
Class IActive
Advance Medical Solutions Anterior Access Kit Light 012104
FDA UDI
Class IActive
Lumitex Medical Devices Adapter - Olympus 012141
FDA UDI
Class IActive
SeaSpine OLYMPUS Cable Adapter 007979
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Dec 11, 2019Z-0923-2020—terminated

There is a potential for some systems built between 2014 and Jan 2018 to have a light output falling below the recommended minimum output. This problem has been associated with exposure of the light pipe to elevated temperatures, which is contra-indicated in the Operation, Maintenance, and Service Manual.

Jul 1, 2009Z-1998-2009—terminated

Adhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifications. The adhesive strip provided may not have met Lumitex requirements to be medical grade, EtO compatible, and biocompatible.