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Sign in to claim this brandOsteosymbionics, LLC
US
Last updated May 30, 2026
What Osteosymbionics, LLC makes
Osteosymbionics, LLC manufactures cranioplasty plates designed for cranial reconstruction, including both non-alterable and patient-specific options made from materials like PEEK. The company also produces chin prostheses and temporalis implants, which are used in reconstructive surgeries for facial and cranial defects.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) pathway and the Unique Device Identification (UDI) system. These products are listed in the FDA’s regulatory databases, ensuring compliance with US medical device standards.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Osteosymbionics, LLC manufacture?
Osteosymbionics, LLC manufactures cranioplasty plates for cranial reconstruction, including non-alterable and patient-specific options made from materials like PEEK. The company also produces chin prostheses and temporalis implants used in reconstructive surgeries for facial and cranial defects.
Where is Osteosymbionics, LLC based?
Osteosymbionics, LLC is based in the United States, as indicated by the country designation in the device data.
Which regulatory registries list Osteosymbionics' devices?
Osteosymbionics' devices are listed in the FDA's 510(k) database and the Unique Device Identification (UDI) system, ensuring compliance with US medical device standards.
How are Osteosymbionics' devices classified?
Osteosymbionics' devices are classified as Class II under FDA regulations, which means they are subject to general controls and special controls to ensure their safety and effectiveness.
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
- 858769651
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PK Shield | IMP-PK | FDA UDI | Class II | Active |
| ClearShield (Sterile) | SIMP | FDA UDI | Class II | Active |
| ClearShield (Non-Sterile) | IMP | FDA UDI | Class II | Active |
| ST Temporalis | STT-50 | FDA UDI | Class II | Active |
| ST Temporalis | STT-60 | FDA UDI | Class II | Active |
| Osteosymbionics Peek Cranial Implant | K121102 | FDA 510(k) | Class II | Active |
| Osteosymbionics Patient-Specific Cranial Plate | K133082 | FDA 510(k) | Class II | Active |
| Osteosymbionics Patient Specific Cranial Implant | K072601 | FDA 510(k) | Class II | Active |
| Osteosymbionics, St Temporalis Implant | K111069 | FDA 510(k) | Class II | Active |
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