Duns Number:109903521
Device Description: 4.0MM CANNULATED CORTEX REAMER F/4.0MM CANNULATED SCREW 4.0MM CANNULATED CORTEX REAMER F/4.0MM CANNULATED SCREWS
Catalog Number
117067
Brand Name
Cannulated Screws
Version/Model Number
117067
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
K123055
Product Code
HRS
Product Code Name
PLATE, FIXATION, BONE
Public Device Record Key
583a2596-8ee8-4b84-98b9-1b6060f9d5cd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 25, 2015
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |