Duns Number:268469389
Device Description: The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system in The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended to replace a vertebral body. It is designed for use in the cervical and in the thoracolumbar spine (C3 - L5) to replace a collapsed, damaged or unstable vertebral body during tumor or trauma management and to replace a partially removed vertebral body in the management of degenerative disorders.
Catalog Number
100112528
Brand Name
SUPSTANCE Small
Version/Model Number
100112528
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
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
830b0669-d537-4932-a11a-ad96059d0386
Public Version Date
February 24, 2020
Public Version Number
3
DI Record Publish Date
November 12, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 98 |