Duns Number:828829072
Catalog Number
-
Brand Name
3.5mm x 22mm Gridlock Ankle Locking Screw
Version/Model Number
305-35-022
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"
Yes
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
K160177
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
755de58e-ca72-41f0-8cfc-66836b3c1e5c
Public Version Date
April 06, 2022
Public Version Number
4
DI Record Publish Date
March 06, 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 | 345 |
2 | A medical device with a moderate to high risk that requires special controls. | 933 |