Duns Number:062355158
Device Description: Half Pin, 6.0/250/40mm, Self Drilling, QC, SS - Non-Sterile
Catalog Number
-
Brand Name
Smart Correction
Version/Model Number
50-1860-254S-WBNS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2022
Issuing Agency
In HIBCC
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
K193368
Product Code
KTT
Product Code Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Public Device Record Key
589c7407-92c4-485b-95a6-eef27e940743
Public Version Date
October 03, 2022
Public Version Number
3
DI Record Publish Date
May 13, 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 | 142 |
2 | A medical device with a moderate to high risk that requires special controls. | 1453 |