FDA Registration Active 🇺🇸 United States

Lumitex Medical Devices, Inc.

Reg #: 1000122810 · FEI: 1000122810 · Expires 2026
Products
3
Proprietary Names
129
Establishment Types
3
Classifications
3

Registration Details

Registration Name
Lumitex Medical Devices, Inc.
Registration Number
1000122810
FEI Number
1000122810
Status
Active
Expiry Year
2026
Initial Importer
No
Address
6611 W Snowville Rd
City
Brecksville
State
OH
ZIP
44141
Country
US

Regulatory Submissions

510(k) Number
K053568

Owner / Operator

Firm Name
Lumitex Medical Devices, Inc.
Operator Number
9000093
Address
6611 W Snowville Rd, --
City
Brecksville
State
OH
Postal Code
44141
Country
US
Correspondent
Kimberly S Tetuan

Products

Device Name Product Code
Bedding, Disposable, Medical KME
Unit, Neonatal Phototherapy LBI
Retractor, Fiberoptic FDG

Proprietary Names

Bilisoft 2 Phototherapy System, English Large Pad Bilisoft 2 Phototherapy System, Large Pad Bilisoft 2 Phototherapy System, Small Pad Bilisoft 2 Phototherapy System, English Small Pad Bilisoft Phototherapy System Giraffe Blue Spot PT Lite Medtronic Surgical Illuminator - Blade CoreLink Surgical Illuminator 3mm MAX Cable Diameter Medacta Adapter ACMI Spinal Elements Storz Cable Adapter Thompson Surgical Instruments Lite Path Adhesive S 120mm Globus Medical 4mm Wolf Cable Adapter K2M Canyon Retractor Systems 18mm Pinnacle Surgical Illuminator 4mm MAX Cable Diameter Triton Medcial Port Illuminator 4mm MAX Cable Diameter Bones and Nerves Surgical Disposable Single Leg Surgical Illuminator 3.75 mm MAX Cable Diameter Depuy 4mm Wolf Reusable Light Cable Lumitex 3.75mm ACMI Reusable Light Cable MiRus Bifurcated Illuminator 4mm MAX Cable Diameter Seaspine Olympus Cable Adapter Spineart ACMI Cable Adapter BLACK & BLACK Surgical LumiView Mini 4mm MAX Cable Diameter Lumitex 3.5mm ACMI Bifurcated reusable light cable Medacta Adapter Storz Precision Spine TLIF Bifurcated Surgical Illuminator 4mm MAX Cable Diameter Camber Spine MIS Surgical Illuminator 3.75mm MAX Cable Diameter Globus Medical 4mm Olympus Cable Adapter Orthofix Surgical Illuminator Spineart Surgical Illuminator 2.5mm MAX cable Diameter Camber Spine Intermediary Fiber Optic Cable Globus Medical 4mm ACMI Cable Adapter Orthofix Pro-View Minimal Access Portal System Seaspine Storz Cable Adapter Spineart Storz Cable Adapter K2M Canyon Retractor Systems 26mm Depuy 4mm Storz Reusable Light Cable In'Tech Medical 40mm Surgical Illuminator 2.5mm MAX Cable Diameter Invictus Surgical Illuminator 4mm MAX Cable Diameter K2M Light Adapter - Wolf Lumitex ACMI 3.75mm fiber optic cable Seaspine Wolf Cable Adapter Globus Medical MARS Port Illuminator- 26mm 4mm MAX Cable Diameter K2M Canyon Retractor Systems 24mm K2M Light Adapter - Olympus Lumitex 4mm ACMI Fiber Optic Cable Globus Medical 4mm Universal Reusable Light Cable Pinnacle 4mm ACMI Reusable Light Cable Spineart Wolf Cable Adapter Bones and Nerves Surgical Disposable Bifurcated Surgical Illuminator 3.75 mm MAX Cable Diameter Lumitex 3.5mm Universal Bifurcated Fiber Optic Cable Medacta Surgical Illuminator 4mm MAX Cable Diameter SeaSpine MIS Retractor Illuminator, Disposable 4mm MAX cable Diameter Spineart 2.8mm Bifurcated Universal Fiber Optic Cable Depuy 3mm ACMI Resuable Light Cable Globus Medical MIS Blade Illuminator 4mm MAX Cable Diameter Medacta Adapter Olympus Spinal elements TLIF Retractor Light 3.5mm MAX Cable Diameter 4WEB Medical OA51S Surgical Illuminator Depuy 4mm ACMI Reusable Light Cable Globus Medical MIS Illumination System 4mm MAX Cable Diameter Spinal Elements Wolf Cable Adapter Camber Spine Technologies OLIF Surgical Illuminator 4mm MAX Cable Diameter K2M Niagara Lateral Access System Lumitex ACMI Cable Adapter Spinal Elements 22mm Port Illuminator 3.25mm MAX Cable Diameter Advanced Medical Solutions 3.5mm ACMI Bifurcated Reusebale Light Cable Choice Spine Surgical Illuminator 4mm MAX Cable Diameter Lumitex Olympus Cable Adapter Spinal Elements 26mm Port Illuminator 3.25mm Max cable Diameter Depuy 4mm Olympus Reusable Light Cable In'Tech 30mm surgical illuminator 2.5mm MAX cable diameter Spineart 2.5mm Universal Fiber Optic Cable Advanced Medical Soultions Anterior Access Kit 4mm MAX Cable Diameter CoreLink 2.8mm ACMI Reusable Light Cable Lumitex Storz Cable Adapter Spinal Elements ACMI Cable Adapter Globus Medical 4mm Storz Cable Adapter Pinnacle 4mm ACMI Bifurcated Reusable Light Cable Spineart Surgical Illuminator 2.8mm MAX cable Diameter Boss Medical LightMat Surgical Illuminator Depuy TSS Retractor Light Strip 4mm MAX Cable Diameter Novus N-Sight Disposable Surgical Light 4mm MAX Cable Diameter SeaSpine Retractor Illuminator 2.5mm MAX Cable Diameter Spineart Olympus Cable Adapter June Medical Galaxy II LUX Connect K2M Reusable Light Cable Medtronic 4mm STORZ Cable Adapter Bones and Nerves Surgical 3.75mm Resuable Fiber Optic Cable Lumitex 3.5mm Bifurcared fiber optic cable Medacta Apdapter Wolf Seaspine ACMI Cable Adapter Alphatec Spine 3mm Universal Reusable Light Cable CoreLink Bifurcated Illuminator 3mm MAX Cable Diameter Lumitex Wolf Cable Adapter Spinal Elements Olympus Cable Adapter Medtronic 4mm OLYMPUS Cable Adapter Medtronic 4mm ACMI Cable Adapter CoreLink Disposable- Ring Clip- 26MM 3.75mm MAX Cable Diameter Medacta 4mm Universal Reusable Light Cable Spinal Elements PL Retractor Light K2M Light Adapter - Storz Lumitex 4mm Universal Fiber Optic Cable BLACK & BLACK Surgical LumiView Midi 4mm MAX Cabel Diameter Life Spine Surgical Illuminator 4mm MAX Cable Diameter Precision Spine Surgical Illuminator 4mm MAX cable Diameter Altus Spine Bifurcated Illuminator K2M Canyon Retractor Systems 16mm LESSpine Malleable Illuminator 4mm MAX Cable Diameter Precision Spine 4mm ACMI Reusable Light Cable K2M Light Adapter - ACMI Light Cable, Vaginal Retractor K2M ATP Access System Koros Surgical Illuminator 2.5mm MAX Cable Diameter K2M Canyon Retractor Systems Lattus Spine Surgical Illuminator Pioneer Technology Surgical Illuminator 4mm MAX Cable Diameter Globus Medical MARS Port Illuminator- 22mm 4mm MAX Cable Diameter K2M Canyon Retractor Systems 22mm Thompson Surgical Instruments Lite Path Integrated D 13mm In'Tech Medical 60mm Surgical Illuminator 2.5mm MAX Cable Diameter Astura Medical Bifurcated Surgical Illuminator Life Instruments Life Light Surgical Illuminator 4mm MAX Cable Diameter Precision Spine Midline Cortical Surgical Illuminator Globus Medical MARS Port Illuminator- 19mm 4mm MAX Cable Diameter K2M Canyon Retractor Systems 20mm Zimmer Biomet Spine Timberline Lateral Fusion System Wave Guide 3.5mm MAX Cable Diameter Medtronic 4mm WOLF Cable Adapter Medtronic 4mm Universal Reusable Light Cable Medtronic Surgical Illuminator - 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Establishment Types

Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device