TRAXIO WEIGHT SYSTEM - COMPLETE - SIZE 3

Primary DI
07540153900053
Brand
TRAXIO WEIGHT SYSTEM - COMPLETE - SIZE 3
Company
Groupe Synetik Inc
Model
300-00001-W3
Catalog number
300-00001-W3
Device description
TRAXIO Weight System is a non-powered, mechanical halo-gravity traction system intended to generate and maintain a prescribed axial traction load for pediatric patients requiring gradual spinal realignment in a controlled hospital environment under the supervision of qualified healthcare professionals. The complete system includes an adjustable traction frame, a wheelchair module, a walker module, and an inclined traction pulley assembly. These included components allow the system to be configured for seated traction using the wheelchair, standing and walking traction using the walker, or inclined traction using the dedicated pulley assembly. The traction mechanism consists of a rope-and-pulley system, an enclosed weight locker containing a weight carriage and removable weight plates, and a dedicated clip interface for connection to a compatible cranial halo ring. The frame includes a base, a height-adjustable vertical post, and a length-adjustable horizontal pole supporting the traction pulleys. Traction is generated by the suspended weight carriage and selected weight plates and transmitted through the rope to the halo attachment. A tension blocker allows the traction mechanism to be secured during designated handling procedures. The cranial halo ring and fixation pins are not supplied with TRAXIO and must be obtained separately as a compatible, separately cleared system. Device configuration, traction load selection, adjustments, and patient monitoring must be performed by qualified healthcare professionals in accordance with the instructions for use.
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSTApparatus, Traction, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSTApparatus, Traction, Non-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540153900053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540153900053075401539000537540153900053

Contacts#

Phone, Email table
PhoneEmail
1-866-739-2400client@synetikgroup.com

Regulatory Flags#

DUNS number
248158300
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540153900015TRAXIO WEIGHT SYSTEM - COMPLETE - SIZE 2300-00001-W2300-00001-W22026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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