FDA.reportPublic FDA data

TL-HEX TRUELOK HEXAPOD SYSTEM

Primary DI
18053800895917
Brand
TL-HEX TRUELOK HEXAPOD SYSTEM
Company
ORTHOFIX SRL
Model
1
Catalog number
50-20010
Device description
TL-HEX KIT ID FRAME ADULT
Published
2021-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILTAdaptor, Recreational

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILTAdaptor, RecreationalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18053800895917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805380089591718053800895917

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking stickerA hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
0456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18059015375831OrthoNext™ Platform System Software2.1ORTHONEXTSW2.12025-01-31
18059015375848OrthoNext™ Platform System Software1.1TLHEXMODULESW1.12025-01-31
18052469476444OrthoNext™ Platform System Software1.0TLHEXMODULESW2023-03-31
18052469476451OrthoNext™ Platform System Software1.0MYHEXPLANSW2023-03-31
18053340345675OrthoNext™ Platform System Software2.0ORTHONEXTSW2023-03-31
18053340345682OrthoNext™ Platform System Software1.1JPSMODULESW2023-03-31
18032568033229Surgical Instruments1136202026-07-23
18032568033236Surgical Instruments1136212026-07-23
18032568036008WRIST FIXATION SYSTEMS1360082026-07-23
18059015376838Fitbone Transport and Lengthening System199-600038172026-07-23
18059015376845Fitbone Transport and Lengthening System199-600038182026-07-23
18059015376852Fitbone Transport and Lengthening System199-600038192026-07-23
18059015376869Fitbone Transport and Lengthening System199-600038202026-07-23
18059015376876Fitbone Transport and Lengthening System199-600038212026-07-23
18059015376883Fitbone Transport and Lengthening System199-600038222026-07-23
18059015376890Fitbone Transport and Lengthening System199-600038232026-07-23
18059015376906Fitbone Transport and Lengthening System199-600038242026-07-23
18059015376913Fitbone Transport and Lengthening System199-600038252026-07-23
18059015376920Fitbone Transport and Lengthening System199-600038262026-07-23
18059015376937Fitbone Transport and Lengthening System199-600038272026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429651096Lumo Hold O-2macu4 GmbHILT2026-07-18
04262429651102Lynk Hold Lock O-2macu4 GmbHILT2026-07-18
04262429650204Lynk Hook Module standardmacu4 GmbHILT2025-11-23
04262429650211Lynk Push Module standardmacu4 GmbHILT2025-11-23
04262429650228Lynk Hold STD Modulemacu4 GmbHILT2025-11-23
04262429650235Lynk Clic Modulemacu4 GmbHILT2025-11-23
04262429650242Lynk Clic Head 360°macu4 GmbHILT2025-11-23
04262429650259Lynk Clic Head 70°macu4 GmbHILT2025-11-23
04262429650266Lynk Clic Head 0°macu4 GmbHILT2025-11-23
04262429650273Lynk Clic Adaptermacu4 GmbHILT2025-11-23
04262429650327Lynk Clic Lock Modulemacu4 GmbHILT2025-11-23
04262429650334Lynk Clic Lock Head 360°, STDmacu4 GmbHILT2025-11-23
04262429650341Lynk Clic Lock Head 70°, STDmacu4 GmbHILT2025-11-23
04262429650358Lynk Clic Lock Head 0°, STDmacu4 GmbHILT2025-11-23
04262429650365Lynk Clic Lock Adaptermacu4 GmbHILT2025-11-23
04262429650372Lynk Hold Lock Modulemacu4 GmbHILT2025-11-23
04262429650389Lumo Cuff, STD-SML-Amacu4 GmbHILT2025-11-23
04262429650396Lumo Shovel, STDmacu4 GmbHILT2025-11-23
04262429650402Lumo Hold, Lockmacu4 GmbHILT2025-11-23
04262429650419Lumo Roll, STDmacu4 GmbHILT2025-11-23
04262429650426Lumo Clamp, STDmacu4 GmbHILT2025-11-23
04262429650433Lynk Clic Lock Head 70°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650440Lynk Clic Lock Head 0°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650457Lynk Clic Lock Head 360°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650464Lynk Clic Lock Head 70°, FLATmacu4 GmbHILT2025-11-23
04262429650471Lynk Clic Lock Head 360°, FLATmacu4 GmbHILT2025-11-23
04262429650488Lynk Clic Lock Head 0°, FLATmacu4 GmbHILT2025-11-23
04262429650495Lumo Cuff, STD-SML-Bmacu4 GmbHILT2025-11-23
04262429650501Lumo Cuff, STD-SML-Cmacu4 GmbHILT2025-11-23
04262429650518Lumo Cuff, STD-SML-Dmacu4 GmbHILT2025-11-23