Duns Number:431406875
Device Description: Temporary external fixation kit composed of:- Clamp with bone screw ø 6mm L160mm (4 pcs);- Temporary external fixation kit composed of:- Clamp with bone screw ø 6mm L160mm (4 pcs);- Rod to rod clamp (2 pcs);- Rod ø12mm L150mm (1 pc);- Rod ø12mm L200mm (2 pcs);- Hand drill (1 pc).Bone screw material: titanium alloy Ti6Al4V ELI (ASTM F136).
Catalog Number
DF100010
Brand Name
DOLPHIX
Version/Model Number
Basic kit
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K163323
Product Code
JDW
Product Code Name
Pin, Fixation, Threaded
Public Device Record Key
64c68b90-886a-4e57-a6dc-3f0cd67a91a5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 19, 2017
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 | 112 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1181 |