Duns Number:089645059
Device Description: 6.0 x 110mm Screw Fastener ST
Catalog Number
360-1110
Brand Name
6.0 x 110mm Screw Fastener ST
Version/Model Number
360-1110
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
K210247
Product Code
JDO
Product Code Name
Device, Fixation, Proximal Femoral, Implant
Public Device Record Key
cf1058c5-b6c1-4cb7-8410-4524fd058d76
Public Version Date
May 14, 2021
Public Version Number
1
DI Record Publish Date
May 06, 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 | 60 |
2 | A medical device with a moderate to high risk that requires special controls. | 846 |