Duns Number:084042331
Device Description: Halfback50 Lumbar-Sacral Orthosis (LSO) is designed to provide support for spinal injuries 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 PainOsteoporosisDisc DegenerationDisc HerniationPost-Operative FusionLaminectomyDiscectomySpinal StenosisSpondylolisthesisFeatures and Benefits:Low profile; lightweightPatent-pending single-pull cord compression systemThree location gear systemMultiple L-Code configurationsUniversal sizing from 25" to 68"
Catalog Number
HB050
Brand Name
ManaMed
Version/Model Number
Halfback-50
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IQE
Product Code Name
Orthosis, Lumbar
Public Device Record Key
7584c6ec-24a4-44d9-b5a6-f03150bf6e8b
Public Version Date
June 28, 2022
Public Version Number
1
DI Record Publish Date
June 20, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 128 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |