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