Duns Number:041956211
Device Description: CERVICAL PLATE, 1 LEVEL, 20MM
Catalog Number
07-CPR-0120
Brand Name
MATIRA ANTERIOR CERVICAL PLATE SYSTEM
Version/Model Number
07-CPR-0120
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
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
-
Product Code
KWQ
Product Code Name
Appliance, Fixation, Spinal Intervertebral Body
Public Device Record Key
6920cdcb-7ad0-443d-9dd2-ed42ad5ff0f7
Public Version Date
March 29, 2018
Public Version Number
2
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 |