Duns Number:039779098
Device Description: Stainless steel, ring-shaped device that may be added to the Inserter/Extractor. The addit Stainless steel, ring-shaped device that may be added to the Inserter/Extractor. The addition of this device provides an additional level of robustness to the mechanism that attaches the inserter to the CurvaFix Implant
Catalog Number
RLI-002
Brand Name
Ring Lock, Long Inserter
Version/Model Number
RLI-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
363e705e-b168-4b3e-9ecc-0b330a4d6a78
Public Version Date
June 28, 2022
Public Version Number
1
DI Record Publish Date
June 20, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |