Duns Number:039779098
Device Description: Reusable surgical instrument used to engage the proximal end of the flexible CurvaFix® IM Reusable surgical instrument used to engage the proximal end of the flexible CurvaFix® IM Implant in preparation for insertion into the intramedullary canal for implantation. If needed, device can also be used to engage the implant during a removal procedure.
Catalog Number
CIA-001
Brand Name
Inserter/Extractor
Version/Model Number
CIA-001
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
K180050
Product Code
HSB
Product Code Name
Rod, Fixation, Intramedullary And Accessories
Public Device Record Key
3210424a-7b95-4f03-8c66-57cb1be966df
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 |