Halfback2-50

Basic Information

• Brand Name: Halfback2-50
• Primary DI: 00810113682884
• Version / Model: HB050-2
• Catalog Number: HB050-2
• 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: fefaaeb2-fde7-4c0e-869e-e1ffc2efbf38

Device Description

Halfback2-50 Lumbar-Sacral Orthosis (LSO) is designed to provide support for spinal injuries and conservative treatments of spinal injuries. Halfback50 provides superior sagittal and coronal control and support from T9-S1. Common Indications for Use: Low Back Pain Osteoporosis Disc Degeneration Disc Herniation Post-Operative Fusion Laminectomy Discectomy Spinal Stenosis Spondylolisthesis Features and Benefits: Low profile; lightweight Patent-pending dual-pull cord compression system Three location gear system Multiple L-Code configurations Universal sizing from 25" to 68"

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
IPY	Orthosis, Lumbo-Sacral	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
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	00810113682884	GS1

Customer Contacts

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