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Sign in to claim this brandORTHOGEM LTD
US
Last updated May 25, 2026
What ORTHOGEM LTD makes
Orthogem Ltd manufactures synthetic bone graft materials designed for orthopedic and spinal applications, including porous and bioactive scaffolds for bone regeneration and fusion procedures.
The company’s portfolio is regulated under FDA Class II devices and appears in the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.
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 Orthogem Ltd manufacture?
Orthogem Ltd specializes in synthetic bone graft materials, primarily used in orthopedic and spinal applications. These devices are designed as porous and bioactive scaffolds to support bone regeneration and fusion procedures, helping patients recover from fractures, joint replacements, or spinal surgeries.
Where is Orthogem Ltd based, and how does that affect its regulatory oversight?
Orthogem Ltd is based in the United States, which means its devices fall under the jurisdiction of the FDA. Since the company’s products are classified as Class II devices, they undergo premarket notification (510(k)) and unique device identification (UDI) requirements to ensure safety and effectiveness before entering the market.
Which regulatory registries list Orthogem Ltd’s devices, and why are these important?
Orthogem Ltd’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate, while the UDI system ensures accurate identification, tracking, and traceability of medical devices throughout their lifecycle, improving patient safety and regulatory compliance.
How are Orthogem Ltd’s devices classified, and what does that classification mean?
Orthogem Ltd’s devices are classified as FDA Class II, which means they pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. This classification requires manufacturers to submit a 510(k) premarket submission to demonstrate compliance with regulatory requirements before commercial distribution.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 220574912
Catalogue (57)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TriPore | 1105-0805 | FDA UDI | Class II | Unknown |
| TriPore | 1104-1202 | FDA UDI | Class II | Active |
| TriPore | 1104-0805 | FDA UDI | Class II | Active |
| PURblue | P1104-1202 | FDA UDI | Class II | Active |
| PURblue | P1102-1205 | FDA UDI | Class II | Active |
| TriPore | 1105-1210 | FDA UDI | Class II | Unknown |
| TriPore | 1103-1215 | FDA UDI | Class II | Active |
| PURblue | P1103-2430 | FDA UDI | Class II | Active |
| TriPore | 3107-0002 | FDA UDI | Class II | Active |
| TriPore | 1105-0505 | FDA UDI | Class II | Unknown |
| TriPore | 1105-1220 | FDA UDI | Class II | Unknown |
| TriPore | 1102-1210A | FDA UDI | Class II | Active |
| TriPore | 1103-2410 | FDA UDI | Class II | Active |
| TriPore | 1104-1205 | FDA UDI | Class II | Active |
| PURblue | P1104-0805 | FDA UDI | Class II | Active |
| TriPore | 1102-1208A | FDA UDI | Class II | Active |
| TriPore | 1102-1408A | FDA UDI | Class II | Active |
| TriPore | 1105-0510 | FDA UDI | Class II | Unknown |
| TriPore | 1105-0820 | FDA UDI | Class II | Unknown |
| TriPore | 1103-2420 | FDA UDI | Class II | Active |
| TriPore | 1105-0810 | FDA UDI | Class II | Unknown |
| TriPore | 1103-2430 | FDA UDI | Class II | Active |
| PURblue | P1104-0802 | FDA UDI | Class II | Active |
| PURblue | P1103-1210 | FDA UDI | Class II | Active |
| PURblue | P1102-1410 | FDA UDI | Class II | Active |
| TriPore | 1102-1410A | FDA UDI | Class II | Active |
| PURblue | P1102-1405 | FDA UDI | Class II | Active |
| PURblue | P3107-0002 | FDA UDI | Class II | Active |
| PURblue | P1102-1412 | FDA UDI | Class II | Active |
| TriPore | 1103-2415 | FDA UDI | Class II | Active |
| TriPore | 1104-2405 | FDA UDI | Class II | Active |
| PURblue | P3107-0001 | FDA UDI | Class II | Active |
| TriPore | 1102-1405A | FDA UDI | Class II | Active |
| TriPore | 1105-0815 | FDA UDI | Class II | Unknown |
| PURblue | P1102-1212 | FDA UDI | Class II | Active |
| PURblue | P1102-1408 | FDA UDI | Class II | Active |
| PURblue | P1103-1215 | FDA UDI | Class II | Active |
| PURblue | P1103-2415 | FDA UDI | Class II | Active |
| PURblue | P1103-2420 | FDA UDI | Class II | Active |
| TriPore | 1105-0515 | FDA UDI | Class II | Unknown |
| TriPore | 1102-1205A | FDA UDI | Class II | Active |
| PURblue | P1103-2410 | FDA UDI | Class II | Active |
| TriPore | 1103-1210 | FDA UDI | Class II | Active |
| TriPore | 3107-0001 | FDA UDI | Class II | Active |
| PURblue | P1104-2405 | FDA UDI | Class II | Active |
| TriPore | 1104-0802 | FDA UDI | Class II | Active |
| TriPore | 1102-1412A | FDA UDI | Class II | Active |
| TriPore | 3107-0003 | FDA UDI | Class II | Unknown |
| TriPore | 1102-1212A | FDA UDI | Class II | Active |
| PURblue | P1102-1210 | FDA UDI | Class II | Active |
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