CERASORB® Ortho Foam 1 x 1.2 cc

GUDID ECURCOM2512

Device Name: CERASORB® Ortho Foam Mofidication: Mouldable Foam Indication 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.

curasan AG

Bone matrix implant, composite

• Primary Device ID: ECURCOM2512
• NIH Device Record Key: 17b25a0f-069b-4089-ae06-a8c67ec8f570
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERASORB® Ortho Foam
• Version Model Number: 25x12x4 mm
• Catalog Number: 1 x 1.2 cc
• Company DUNS: 324331826
• Company Name: curasan AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ECURCOM2512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160566

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-24

On-Brand Devices [CERASORB® Ortho Foam]

• ECURCOM2550: Device Name: CERASORB® Ortho Foam Mofidication: Mouldable Foam Indication for Use: Cerasorb® O
• ECURCOM2525: Device Name: CERASORB® Ortho Foam Mofidication: Mouldable Foam Indication for Use: Cerasorb® O
• ECURCOM2512: Device Name: CERASORB® Ortho Foam Mofidication: Mouldable Foam Indication for Use: Cerasorb® O
• ECURCOM25100: Device Name: CERASORB® Ortho Foam Mofidication: Mouldable Foam Indication for Use: Cerasorb® O
• ECURCOF6565: Device Name: CERASORB® Ortho Foam Mofidication: Flexible Foam Stripe Indication for Use: Ceraso
• ECURCOF2550: Device Name: CERASORB® Ortho Foam Mofidication: Flexible Foam Stripe Indication for Use: Ceraso
• ECURCOF25100: Device Name: CERASORB® Ortho Foam Mofidication: Flexible Foam Stripe Indication for Use: Ceraso