Duns Number:116722111
Device Description: ArcPhix Compression Screw SystemThe system includes the implant, two guide wires, one cann ArcPhix Compression Screw SystemThe system includes the implant, two guide wires, one cannulated drill, and a driver.
Catalog Number
EXARC903028
Brand Name
ArcPhix System
Version/Model Number
EXARC903028
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"
-
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
-
Product Code
HTW
Product Code Name
Bit, Drill
Public Device Record Key
db66b1c1-8bb7-4a1e-9edc-5fb934cd2632
Public Version Date
August 16, 2021
Public Version Number
5
DI Record Publish Date
April 06, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |