Duns Number:481999654
Device Description: Bone Screw, T5
Catalog Number
662624S
Brand Name
VARIAX
Version/Model Number
662624S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K180500
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
3320ccd6-38cb-4288-ac23-77f6a94202c2
Public Version Date
August 02, 2018
Public Version Number
1
DI Record Publish Date
July 02, 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 | 2606 |
2 | A medical device with a moderate to high risk that requires special controls. | 9953 |
3 | A medical device with high risk that requires premarket approval | 186 |