Duns Number:947090650
Device Description: Radiolucent Spine positioning traction frame. Arcing flexures are used to arc the patients Radiolucent Spine positioning traction frame. Arcing flexures are used to arc the patients spine while in the prone position to expose the spine for surgical procedures.
Catalog Number
-
Brand Name
Tenzor Radiolucent Carbon Fiber Spine Positioning Frame
Version/Model Number
4-0009-001
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BWN
Product Code Name
Table And Attachments, Operating-Room
Public Device Record Key
bd6c9ad7-3c3e-4fb5-8a2e-1878919db0f6
Public Version Date
February 24, 2020
Public Version Number
1
DI Record Publish Date
February 14, 2020
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |