Matriform SI-Strip 1 x 5 cc

GUDID ECUR449050

Device Name: Matriform SI-Strip Indication for Use: Matriform® Si Strip is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Matriform® Si Strip is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process

curasan AG

Bone matrix implant, composite

• Primary Device ID: ECUR449050
• NIH Device Record Key: 65b510ef-8a67-4898-bc38-722ab4537474
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Matriform SI-Strip
• Version Model Number: 50x25x4 mm
• Catalog Number: 1 x 5 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

Customer Support Contacts

• Phone: +496027409000
• Email: info@curasan.de

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ECUR449050 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-28
• Device Publish Date: 2020-02-20

On-Brand Devices [Matriform SI-Strip]

• ECUR449100: Device Name: Matriform Strip Indication for Use: Matriform® Si Strip is intended to fill bony v
• ECUR449050: Device Name: Matriform SI-Strip Indication for Use: Matriform® Si Strip is intended to fill bon