Duns Number:830350380
Device Description: ENDCAP 436020305 EXTND 20 X 30MM 15 DEG
Catalog Number
-
Brand Name
T2 STRATOSPHERE™ Expandable Corpectomy System
Version/Model Number
436020305
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
K173125
Product Code
MQP
Product Code Name
Spinal vertebral body replacement device
Public Device Record Key
b4df5196-960a-4f41-aff9-4ef351aafa52
Public Version Date
August 05, 2019
Public Version Number
1
DI Record Publish Date
July 28, 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 |