Duns Number:344203948
Device Description: The ATHLET VBR System is a lordotic, modular vertebral body replacement system. Caudal and The ATHLET VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used between one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth.
Catalog Number
ATM309
Brand Name
ATHLET
Version/Model Number
Connection screw
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQP
Product Code Name
Spinal Vertebral Body Replacement Device
Public Device Record Key
e2d36e3e-adea-4726-93b1-f566be1b8ae9
Public Version Date
November 05, 2019
Public Version Number
9
DI Record Publish Date
September 24, 2015
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 | 522 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1837 |