Duns Number:039779098
Device Description: Reusable surgical instrument used during pelvic fixation procedure to convert a flexible i Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture.
Catalog Number
CLA-001
Brand Name
Lock Activator
Version/Model Number
CLA-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
f2c32d3e-a7ae-4bcd-8b84-6100977733be
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 |