Duns Number:623316978
Device Description: Implant Caddy
Catalog Number
2200-0001
Brand Name
ENDOSKELETON® TA VBR
Version/Model Number
2200-0001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 18, 2020
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
-
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
K032812
Product Code
MQP
Product Code Name
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Public Device Record Key
f75d41c0-66f2-422a-8722-bcfaf332e161
Public Version Date
September 16, 2022
Public Version Number
12
DI Record Publish Date
December 15, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 243 |
2 | A medical device with a moderate to high risk that requires special controls. | 5255 |