Duns Number:218648211
Device Description: K-WIRE FOR 3.0MM SCREW SINGLE TROCAR 1.0 X 90MM (CoCr)
Catalog Number
OS900090-NS
Brand Name
OrthoSolutions 'System26' Bone Screws
Version/Model Number
OS900090-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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K163489
Product Code
HTY
Product Code Name
Pin, Fixation, Smooth
Public Device Record Key
0c494a38-958b-44cc-a6b1-456420c024c6
Public Version Date
October 01, 2018
Public Version Number
1
DI Record Publish Date
August 30, 2018
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 |