Duns Number:218648211
Device Description: 5.0MM CANN. SCREW PIN 2.0MM X 9 inches BAYONET TIP
Catalog Number
OS323011
Brand Name
ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
Version/Model Number
OS323011
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
K110895,K110895
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
75a849ea-c4f2-48a0-bda6-fed786c1e84c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 08, 2016
Package DI Number
05055662934779
Quantity per Package
10
Contains DI Package
05055662934786
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboard Box
| 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 |