OSferion

Primary DI
04560245656913
Brand
OSferion
Company
OSFERIONBIOMATERIALS CORP.
Model
AR-13370-4
Catalog number
AR-13370-4
Device description
OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids.
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080065000OSFERIONOlympus Terumo Biomaterials Corporation2008-05-02MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560245656913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560245656913045602456569134560245656913

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Millimeter
Length12Millimeter
Length15Millimeter
Length35Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
964420077
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560245656883OSferionAR-13370-1AR-13370-12015-09-24
04560245656890OSferionAR-13370-2AR-13370-22015-09-24
04560245656906OSferionAR-13370-3AR-13370-32015-09-24
04560245656951OSferionAR-13372-1AR-13372-12015-09-24
04560245656968OSferionAR-13372-2AR-13372-22015-09-24
04560245656975OSferionAR-13372-3AR-13372-32015-09-24

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