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US
Last updated May 24, 2026
What OSTEOPORE INTERNATIONAL PTE. LTD. makes
Osteopore International manufactures synthetic, non-antimicrobial bone matrix implants designed for surgical applications. Their portfolio includes plug-shaped implants (Osteoplug and Osteoplug-C), mesh-based scaffolds (Osteomesh), and strip-like constructs (Osteostrip), intended for bone void filling and structural support in orthopedic procedures.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable medical device regulations for synthetic bone substitutes.
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 Osteopore International manufacture?
Osteopore International specializes in synthetic, non-antimicrobial bone matrix implants. Their product line includes three main forms: plug-shaped implants (such as Osteoplug and Osteoplug-C), mesh-based scaffolds (like Osteomesh), and strip-like constructs (such as Osteostrip). These devices are designed for surgical applications, specifically to fill bone voids and provide structural support in orthopedic procedures.
Where is Osteopore International based, and what regulatory region does it operate in?
Osteopore International is based in the United States. As a manufacturer, the company develops its devices in accordance with U.S. medical device regulations, which govern synthetic bone substitutes and ensure compliance with safety and performance standards for surgical implants.
How are Osteopore International’s devices classified under regulatory frameworks?
Osteopore International’s bone matrix implants are classified as Class II devices. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness, such as those used in orthopedic reconstruction or bone void filling.
Are Osteopore International’s devices listed in any regulatory registries?
Yes, Osteopore International’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for regulatory and clinical purposes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- osteopore.com
- —
- —
- [email protected]
- Phone
- 9999999999
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 894834738
Catalogue (35)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Osteoplug | PC22(9,9,4) | FDA UDI | Class II | Active |
| Osteomesh | PTSH-039-025-001-P2 | FDA UDI | Class II | Active |
| Osteomesh | PC11(50,50,2) | FDA UDI | Class II | Active |
| Osteomesh | PC12(39,10,1.25) | FDA UDI | Class II | Active |
| Osteoplug | PC23(14,14,4) | FDA UDI | Class II | Active |
| Osteoplug-C | CHBP-1305-P | FDA UDI | Class II | Active |
| Osteostrip | PC18(60,2,4) | FDA UDI | Class II | Active |
| Osteostrip | PC17(100,2,4) | FDA UDI | Class II | Active |
| Osteostrip | PC18(60,3.5,4) | FDA UDI | Class II | Active |
| Osteoplug | PC22(13,13,4) | FDA UDI | Class II | Active |
| Osteoplug | PC23(13,13,4) | FDA UDI | Class II | Active |
| Osteoplug-C | PC24(11,11,4) | FDA UDI | Class II | Active |
| Osteoplug-C | PC24(14,14,4) | FDA UDI | Class II | Active |
| Osteoplug-C | CHBP-0707-S | FDA UDI | Class II | Active |
| Osteoplug | PC23(15,15,4) | FDA UDI | Class II | Active |
| Osteostrip | PC17(100,3.5,4) | FDA UDI | Class II | Active |
| Osteoplug | NEBP-1505-P | FDA UDI | Class II | Active |
| Osteoplug | PC22(14,14,4) | FDA UDI | Class II | Active |
| Osteoplug | PC22(8,8,4) | FDA UDI | Class II | Active |
| Osteomesh | PC11(25,25,1) | FDA UDI | Class II | Active |
| Osteoplug-C | CHBP-1505-P | FDA UDI | Class II | Active |
| Osteoplug-C | PC24(15,15,4) | FDA UDI | Class II | Active |
| Osteoplug | NEBP-1305-P | FDA UDI | Class II | Active |
| Osteoplug | PC22(11,11,4) | FDA UDI | Class II | Active |
| Osteomesh | PC11(50,50,1) | FDA UDI | Class II | Active |
| Osteoplug | PC23(10,10,4) | FDA UDI | Class II | Active |
| Osteoplug | PC26(8,7,4) | FDA UDI | Class II | Active |
| Osteoplug | PC23(11,11,4) | FDA UDI | Class II | Active |
| Osteomesh | PC11(50,50,1.25) | FDA UDI | Class II | Active |
| Osteoplug-C | PC24(13,13,4) | FDA UDI | Class II | Active |
| Osteomesh | PC51(13,8,4,6) | FDA UDI | Class II | Active |
| Osteomesh | PC12(39,10,1) | FDA UDI | Class II | Active |
| Osteoplug | PC22(15,15,4) | FDA UDI | Class II | Active |
| Osteoplug | PC23(9,9,4) | FDA UDI | Class II | Active |
| Osteomesh | PC11(50,50,1.5) | FDA UDI | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Osteopore International Pte Ltd Singapore South West · SG FEI 3007303685