Duns Number:039779098
Device Description: A custom engineered set consisting of reusable implant selection device, housed in a steri A custom engineered set consisting of reusable implant selection device, housed in a sterilizable storage container, that is used during a surgical procedure for the CurvaFix IM Implant.
Catalog Number
CIS-002
Brand Name
Implant Selection Device Set
Version/Model Number
CIS-002
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
a832ab4e-f045-4dba-a66d-718db68ce2c7
Public Version Date
December 10, 2021
Public Version Number
1
DI Record Publish Date
December 02, 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 |