Duns Number:830350380
Device Description: SPACER 4302214 TELAMON P VBS 0 22X14MM
Catalog Number
-
Brand Name
VERTE-STACK® Spinal System
Version/Model Number
4302214
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 08, 2018
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
K031780
Product Code
MQP
Product Code Name
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Public Device Record Key
0ef0f41f-ca70-429d-a0a4-b6620b868e8e
Public Version Date
February 24, 2020
Public Version Number
5
DI Record Publish Date
July 31, 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 | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |