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US
Last updated May 30, 2026
What OSFERIONBIOMATERIALS CORP. makes
OSferion Biomaterials Corp. manufactures synthetic, non-antimicrobial bone matrix implants designed for bone regeneration and reconstruction. These products are intended for use in orthopedic and maxillofacial surgical procedures where structural support or tissue integration is required.
The company’s portfolio is regulated as Class II medical devices in the United States and is listed in the FDA’s Unique Device Identifier (UDI) database. The products are subject to compliance with FDA regulations for Class II devices, ensuring adherence to performance and safety standards.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does OSferion Biomaterials Corp. manufacture?
OSferion Biomaterials Corp. specializes in synthetic, non-antimicrobial bone matrix implants. These devices are primarily designed for bone regeneration and reconstruction, often used in orthopedic and maxillofacial surgeries where structural support or tissue integration is needed. The implants are engineered to integrate with natural bone tissue without releasing antimicrobial agents.
Where is OSferion Biomaterials Corp. based?
OSferion Biomaterials Corp. is based in the United States. The company’s operations and regulatory compliance are aligned with U.S. medical device standards, including those enforced by the FDA.
Which regulatory registries list OSferion Biomaterials Corp.’s devices?
OSferion Biomaterials Corp.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II medical devices, which are subject to specific performance and safety requirements under U.S. regulations.
How are OSferion Biomaterials Corp.’s devices classified under U.S. regulations?
OSferion Biomaterials Corp.’s bone matrix implants fall under Class II classification in the United States. This classification indicates that while the devices pose moderate risk, they require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- arthrex.com
- —
- —
- [email protected]
- Phone
- 800-934-4404
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 964420077
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OSferion | AR-13370-3 | FDA UDI | Class II | Active |
| OSferion | AR-13370-1 | FDA UDI | Class II | Active |
| OSferion | AR-13370-2 | FDA UDI | Class II | Active |
| OSferion | AR-13372-3 | FDA UDI | Class II | Active |
| OSferion | AR-13372-2 | FDA UDI | Class II | Active |
| OSferion | AR-13370-4 | FDA UDI | Class II | Active |
| OSferion | AR-13372-1 | FDA UDI | Class II | Active |
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