Duns Number:830350380
Device Description: ENDCAP 4361305 30MM 15 DEGREE STERILE
Catalog Number
-
Brand Name
T2 STRATOSPHERE Expandable Corpectomy System
Version/Model Number
4361305
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K183510
Product Code
MQP
Product Code Name
Spinal vertebral body replacement device
Public Device Record Key
a550085a-3f18-4457-8f9c-90f6004405ed
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
September 08, 2019
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 |