CERASORB® Ortho Foam - Device Name: CERASORB® Ortho FoamMofidication: - curasan AG

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.

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More Product Details

Catalog Number

1 x 10.0cc

Brand Name

CERASORB® Ortho Foam

Version/Model Number

25x100x4 mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

3ae9ba44-67df-4aa9-82bc-927afa190152

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CURASAN AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 58