Duns Number:060783407
Device Description: StealthFix Ti Implant 4.5mm Post x 15mm Span x 18mm Long
Catalog Number
-
Brand Name
Stealthfix Intraosseous Fixation System
Version/Model Number
SF451518
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
K220181
Product Code
JDR
Product Code Name
Staple, Fixation, Bone
Public Device Record Key
a59f4bfb-7632-4881-8e65-90ddb7113166
Public Version Date
September 23, 2022
Public Version Number
2
DI Record Publish Date
August 04, 2022
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 | 152 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 560 |