Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Lumbar spine orthosis FDA UDI
- Device Name
- Halfback50 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 single-pull cord compression system Three location gear system Multiple L-Code configurations Universal sizing from 25" to 68" FDA UDI
- Model / Reference
- Halfback-50 FDA UDI
- Description
- Halfback50 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 single-pull cord compression system Three location gear system Multiple L-Code configurations Universal sizing from 25" to 68" FDA UDI
Identifiers
- Catalog Number
- HB050 FDA UDI
- Primary DI / UDI-DI
- 00850998008836 FDA UDI
- FDA Product Code
- IQE FDA UDI
- GMDN Term
- Lumbar spine orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Commercial Distribution
- Not 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
ManaMed by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI 7584c6ec-24a4-44d9-b5a6-f03150bf6e8b 35 fields · synced May 30, 2026