Duns Number:324331826
Device Description: Device Name: CERASORB® Ortho FoamMofidication: Mouldable FoamIndication for Use:Cerasorb® Device Name: CERASORB® Ortho FoamMofidication: Mouldable FoamIndication for Use:Cerasorb® ORTHO Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process.
Catalog Number
1 x 2.5 cc
Brand Name
CERASORB® Ortho Foam
Version/Model Number
25x25x2 mm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K160566
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
ee6b25cc-9ac2-4727-9bd1-1861daea26e2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2017
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. | 58 |