Duns Number:062355158
Device Description: Express Kit, Curved 4-Hole x 26mm WishFIX Plate, Instruments and Screws, SS
Catalog Number
XK-EFC0426S
Brand Name
WishFIX
Version/Model Number
XK-EFC0426S-08-US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
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
K182704
Product Code
OBT
Product Code Name
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Public Device Record Key
eca02f19-2dcd-4d8b-9326-6a77589234e3
Public Version Date
December 29, 2021
Public Version Number
1
DI Record Publish Date
December 21, 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 |