Duns Number:089645059
Device Description: Hip Side Plate 130 Degree 6 Hole
Catalog Number
317-31306
Brand Name
Hip Side Plate 130 Deg 6 Hole
Version/Model Number
317-31306
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
KTT
Product Code Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Public Device Record Key
5a503764-77c4-4f5a-a5d4-62002134f8ba
Public Version Date
May 17, 2021
Public Version Number
1
DI Record Publish Date
May 07, 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 |