Duns Number:183641617
Device Description: T Plate, 10mm
Catalog Number
54-08S-10U
Brand Name
Foot and Ankle Plating System
Version/Model Number
54-08S-10U
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
K172973
Product Code
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
861d49ab-2463-42eb-8914-b68c8239b3b7
Public Version Date
November 15, 2019
Public Version Number
1
DI Record Publish Date
November 07, 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 | 315 |
2 | A medical device with a moderate to high risk that requires special controls. | 9180 |
U | Unclassified | 47 |