Duns Number:315494757
Device Description: VBR center piece, size R, Ø 28 mm, height 56-84 mm
Catalog Number
CS 2228-5684-1
Brand Name
VBR™ vertebral body replacement
Version/Model Number
CS 2228-5684-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K003155
Product Code
MQP
Product Code Name
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Public Device Record Key
8cd18643-49d3-4428-8d95-016c551b280d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 30, 2016
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. | 1439 |