Duns Number:697730638
Device Description: OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to f OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids.
Catalog Number
AR-13372-2
Brand Name
OSferion
Version/Model Number
AR-13372-2
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080065
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
52ef863d-9aae-4a44-822b-cfa88fbb950c
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |