OSferion AR-13370-3

GUDID 04560245656906

OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are

OLYMPUS TERUMO BIOMATERIALS CORP.

Bone matrix implant, synthetic

• Primary Device ID: 04560245656906
• NIH Device Record Key: 24bc36a3-a33c-48cb-9ffd-c6d357cb1b7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSferion
• Version Model Number: AR-13370-3
• Catalog Number: AR-13370-3
• Company DUNS: 697730638
• Company Name: OLYMPUS TERUMO BIOMATERIALS CORP.
• 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: 800-934-4404
• Email: complaints@arthrex.com

Device Dimensions

• Length: 12 Millimeter
• Length: 35 Millimeter
• Length: 3 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560245656906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080065

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: 2015-09-24

On-Brand Devices [OSferion]

• 04560245656975: OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill
• 04560245656968: OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill
• 04560245656951: OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill
• 04560245656913: OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill
• 04560245656906: OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill
• 04560245656890: OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill
• 04560245656883: OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill