Duns Number:313267265
Device Description: OsteoBridge IKA Knee Arthrodesis Hex 5.0 mm Screwdriver for DIA 5.0 mm Clamping Screws non OsteoBridge IKA Knee Arthrodesis Hex 5.0 mm Screwdriver for DIA 5.0 mm Clamping Screws non-sterile
Catalog Number
-
Brand Name
OsteoBridge™
Version/Model Number
GA90009
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
HXX
Product Code Name
SCREWDRIVER
Public Device Record Key
a642b566-c79d-4354-89d2-ec42573cbbe5
Public Version Date
October 20, 2022
Public Version Number
2
DI Record Publish Date
November 01, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 328 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1327 |
| U | Unclassified | 13 |