Duns Number:631159324
Device Description: Cervical Plate Screw, Self-drilling, Cylinderical, Variable, Dia 3.5mm, Working length 12. Cervical Plate Screw, Self-drilling, Cylinderical, Variable, Dia 3.5mm, Working length 12.0 mm
Catalog Number
6504-3512
Brand Name
TranS1 Anterior Cervical Plate System
Version/Model Number
6504-3512
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143279
Product Code
KWQ
Product Code Name
Appliance, Fixation, Spinal Intervertebral Body
Public Device Record Key
e04d2a07-f780-4834-a4de-3ab09d5f989d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 19, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25211 |