Duns Number:062355158
Device Description: Express Kit, Curved 4-Hole x 26mm EpiFIX Plate, Instruments and Screws, SS
Catalog Number
XK-EFC0426S
Brand Name
EpiFIX
Version/Model Number
XK-EFC0426S
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
56da53a0-0350-4330-8bc2-e5bab0456e1e
Public Version Date
December 31, 2021
Public Version Number
3
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 |