Duns Number:557801921
Device Description: 2.0mm Cortical Screw*6mm
Catalog Number
220-21006
Brand Name
N/A
Version/Model Number
220-21006
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190391
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
bf385fa1-5e61-4516-b3ac-99f314ea0537
Public Version Date
December 31, 2019
Public Version Number
2
DI Record Publish Date
May 09, 2019
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 1331 |