Duns Number:062355158
Device Description: Express Kit, Curved 4-Hole x 32mm EpiFIX Plate, Instruments and Screws, Ti
Catalog Number
XK-EFC0432T
Brand Name
EpiFIX
Version/Model Number
XK-EFC0432T
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
c0291470-624c-4e7c-a8d0-e14024239af3
Public Version Date
December 31, 2021
Public Version Number
4
DI Record Publish Date
September 15, 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 |