Duns Number:084042331
Device Description: The Cabo (formerly Trailblazer) is one of the lightest double upright braces on the market The Cabo (formerly Trailblazer) is one of the lightest double upright braces on the market. This innovative system features an aluminum alloy frame with a proprietary quick fitting magnetic buckle system.Lightweight and low-profileMagnetic quick releasing bucklesPivoting condyle pads for an optimal fitStep through design
Catalog Number
TRBL45L2
Brand Name
ManaMed
Version/Model Number
Cabo Knee Large Left
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
ITQ
Product Code Name
Joint, Knee, External Brace
Public Device Record Key
4972917b-07aa-4d4e-a25e-585342bdc035
Public Version Date
August 30, 2022
Public Version Number
2
DI Record Publish Date
June 21, 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 |