Duns Number:218648211
Device Description: DRILL GUIDE, 2.4MM VARIABLE ANGLE
Catalog Number
OS721224-NS
Brand Name
Volition™ Plating System
Version/Model Number
OS721224-NS
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K202764
Product Code
PBF
Product Code Name
Orthopaedic Surgical Planning And Instrument Guides
Public Device Record Key
54b319a3-cb9d-450a-bb25-3d05976564bd
Public Version Date
July 05, 2021
Public Version Number
1
DI Record Publish Date
June 25, 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 | 262 |
2 | A medical device with a moderate to high risk that requires special controls. | 1530 |