Duns Number:872194615
Device Description: The Radius plates are made in left & right combination and are designed various length con The Radius plates are made in left & right combination and are designed various length configurations. The plates are contoured to provide a close fit with radius system.
Catalog Number
A3-DND-QF-001-WF3
Brand Name
e-Lock Distal Radius Volar Plate, Extra-Articular, (4 Head Holes), 5 Holes - Lef
Version/Model Number
TI-M14.05
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141680
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
33acdce1-ff30-4436-a2d4-3a2889b246fa
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
November 27, 2018
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1973 |