Duns Number:080024940
Device Description: ORION ø2.5mm Headed Cannulated Screw, Long Thread, Ti - (L)30mm
Catalog Number
HTR-04-254630
Brand Name
ORION
Version/Model Number
HTR-04-254630
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
K153575
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
50e2f9f0-6ac2-454c-99d4-b2fa4c281787
Public Version Date
November 06, 2020
Public Version Number
1
DI Record Publish Date
October 29, 2020
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 913 |