Duns Number:017921066
Device Description: Lumbar Plate System - Thoracolumbar Caddy Lid
Catalog Number
G10014
Brand Name
Lumbar Plate
Version/Model Number
1
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
KWQ
Product Code Name
Appliance, Fixation, Spinal Intervertebral Body
Public Device Record Key
dc7253e0-370a-4b2a-9022-ba8559273ff0
Public Version Date
December 10, 2018
Public Version Number
1
DI Record Publish Date
November 09, 2018
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 | 9 |
2 | A medical device with a moderate to high risk that requires special controls. | 4608 |