Duns Number:047486041
Device Description: Implant is 16mm bridge staple, 16mm x 16mm legs. The Vertex Nitinol Staple System consist Implant is 16mm bridge staple, 16mm x 16mm legs. The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.
Catalog Number
-
Brand Name
Vertex
Version/Model Number
STK-16-16-16
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
K182943
Product Code
JDR
Product Code Name
Staple, Fixation, Bone
Public Device Record Key
9461b9d0-f41c-4853-8516-cc07125e8a97
Public Version Date
November 23, 2021
Public Version Number
2
DI Record Publish Date
December 28, 2020
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 |