Duns Number:830255506
Device Description: Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin, 1ea 1.1mm (0.045") double trocar K-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use.
Catalog Number
2565L3
Brand Name
Intramedullary Fixation Scaffold (IFS)
Version/Model Number
2565L3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
HTY
Product Code Name
Pin, Fixation, Smooth
Public Device Record Key
3cced5b9-a747-4270-ac09-3bbe197604e8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 13, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |