Duns Number:028629553
Device Description: Valeo Corpectomy 17x14mm, 6°, 18mm Height
Catalog Number
11.009.2618
Brand Name
Valeo Spacer System
Version/Model Number
B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
383f1a7a-cd3e-4135-8288-ebbb3c5d5aa5
Public Version Date
December 03, 2018
Public Version Number
4
DI Record Publish Date
December 29, 2017
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 | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 3000 |