Duns Number:860396609
Device Description: SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 10 mm Variable Angle Self Drilling Scre SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 10 mm Variable Angle Self Drilling Screw
Catalog Number
A003.4510
Brand Name
SEA-LINK Anterior Cervical Ø 4.5 mm L 10 mm Variable Angle Self Drilling Screw
Version/Model Number
A003.4510
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
1cc65235-e7fe-4852-8d43-082540525165
Public Version Date
January 28, 2021
Public Version Number
1
DI Record Publish Date
January 20, 2021
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 | 55 |
2 | A medical device with a moderate to high risk that requires special controls. | 124 |