Identity
- Trade Name
- Halfback2-50 FDA UDI
- Generic Name
- Lumbar spine orthosis FDA UDI
- Device Name
- 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" FDA UDI
- Model / Reference
- HB050-2 FDA UDI
- 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" FDA UDI
Identifiers
- Catalog Number
- HB050-2 FDA UDI
- Primary DI / UDI-DI
- 00810113682884 FDA UDI
- FDA Product Code
- IPY FDA UDI
- GMDN Term
- Lumbar spine orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lumbar spine orthosisMultiple spinal region orthosis
Halfback2-50 by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple spinal region orthosis.
- TM "Rehabilitimed" L-4M-3 XXL Comfort — REABILITIMED TOV · Class I
- Trulife — TRULIFE, INC. · Class I
- Trulife — TRULIFE, INC. · Class I
- Trulife — TRULIFE, INC. · Class I
- TM "Rehabilitimed" L-4M-3 L Comfort — REABILITIMED TOV · Class I
- TM "Rehabilitimed" L-4M-2V XXXL Comfort — REABILITIMED TOV · Class I
- Boston Brace — Boston Brace International, Inc. · Class I
- TM "Rehabilitimed" GL-1 XXL Comfort — REABILITIMED TOV · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI fefaaeb2-fde7-4c0e-869e-e1ffc2efbf38 35 fields · synced May 30, 2026