Duns Number:039779098
Device Description: A surgical drilling instrument (6.5mm diameter) intended to be connected to a standard pow A surgical drilling instrument (6.5mm diameter) intended to be connected to a standard power tool, which is used to open and enlarge the medullary canal for the insertion of the CurvaFix IM Implant during a fracture fixation procedure. This device is cannulated so that it can be fed over a guiding wire that has been placed into the correct position inside the bone prior to operation of the drill.
Catalog Number
CFR-065
Brand Name
6.5MM Flexible Reamer
Version/Model Number
CFR-065
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
-
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
HSB
Product Code Name
Rod, Fixation, Intramedullary And Accessories
Public Device Record Key
2b027347-f2bf-4188-a53a-e940d42f9397
Public Version Date
August 19, 2021
Public Version Number
1
DI Record Publish Date
August 11, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |