Duns Number:041956211
Device Description: Driver Shaft, T10 Split Tip
Catalog Number
07-K01-7002
Brand Name
MATIRA ANTERIOR CERVICAL SYSTEM
Version/Model Number
07-K01-7002
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
-
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
HWD
Product Code Name
Starter, Bone Screw
Public Device Record Key
fec7d6b5-d02c-4a41-a45d-b84ea02aee42
Public Version Date
January 10, 2020
Public Version Number
5
DI Record Publish Date
October 31, 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 | 1286 |
2 | A medical device with a moderate to high risk that requires special controls. | 1900 |