Tailback2-64

Basic Information

• Brand Name: Tailback2-64
• Primary DI: 00810113682723
• Version / Model: TB064-2
• Catalog Number: TB064-2
• Company Name: Manamed, Inc.
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-19
• Public Version: 1
• Public Version Date: 2025-09-29
• Public Version Status: New
• Public Device Record Key: 209f0942-e0c4-4cfb-bafb-9b9b48fc0699

Device Description

The Tailback2-64 is a universal thoracic-lumbar-sacral orthosis designed with our patent pending chord compression system with center hub compression technology. It is designed to provide a rigid, spine motion restriction, comfortable, and quick fitting solution for every patient. Ice pack included. Easy application, universal size TLSO Thoracic bar with height adjustments Lightweight, latex-free breathable material Double pulley system

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IPT	Orthosis, Thoracic	Physical Medicine	890.3490	1
IQE	Orthosis, Lumbar	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33031	Lumbar spine orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.	No	Active
41042	Thoracic spine orthosis	A prefabricated (non-customized) orthopaedic corset designed to encompasses the thoracic spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of the abdomen. This is a reusable device.	No	Active
66086	Multiple spinal region orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass two or more regions of the spine (e.g., sacroiliac, lumbosacral, thoracolumbosacral) to support or immobilize deformities, fractures, sprains, or strains of the spine, and may additionally provide support for the abdomen. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113682723	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]