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OSferion

FDA UDI

Class II (US FDA UDI)

by Osferionbiomaterials Corp.

Identity

Trade Name
OSferion FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
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 not intrinsic to the stability of the bony structure. OSferion is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The porosity of OSferion is 60%. Products are supplied in wedges and trapezoids. FDA UDI
Model / Reference
AR-13370-4 FDA UDI
Description
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 not intrinsic to the stability of the bony structure. OSferion is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The porosity of OSferion is 60%. Products are supplied in wedges and trapezoids. FDA UDI

Identifiers

Catalog Number
AR-13370-4 FDA UDI
Primary DI / UDI-DI
04560245656913 FDA UDI
510(k) Number
K080065 FDA UDI
FDA Product Code
MQV FDA UDI
GMDN Term
Bone matrix implant, synthetic, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3045 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 12 Millimeter FDA UDI
Length — 35 Millimeter FDA UDI
Length — 3 Millimeter FDA UDI
Length — 15 Millimeter FDA UDI

Category: Bone matrix implant, synthetic, non-antimicrobial

OSferion by Osferionbiomaterials Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, synthetic, non-antimicrobial.

Cleared under the same submission

K080065 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osferionbiomaterials Corp.

Sources (1)

  • FDA UDI 2e7b0705-af03-4a40-bf64-838e74700c56 37 fields · synced May 30, 2026