Duns Number:047486041
Device Description: Implant: 18mm x 20mm x 8mm Cotton PEEK HA Wedge. The Trigon HA Stand-Alone Wedge Fixation Implant: 18mm x 20mm x 8mm Cotton PEEK HA Wedge. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
Catalog Number
-
Brand Name
Trigon
Version/Model Number
COP-18-20-08
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193414
Product Code
PLF
Product Code Name
Bone Wedge
Public Device Record Key
604ee513-e130-496a-b71e-646b86928786
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
January 29, 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 | 461 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1046 |