Identifiers
- 510(k) Number
- K161090 FDA 510(k)
- FDA Product Code
- GXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5330 FDA 510(k)
- Regulation Number
- 882.5330 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Cranial PSI is a preformed, non-alterable cranioplasty plate made from titanium. It is designed for use in neurology procedures to reconstruct cranial defects following surgery or trauma.
The device is MRI conditional and may heat when subjected to a strong magnetic field. It is supplied with patient-specific accessory devices that include customized fixation arms to facilitate safe and easy cranioplasty procedures. Cranial PSI has FDA 510(k) clearance with product code GXN and is classified as a class II medical device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cranial PSI - OssDsign AB, OssDsign Cranial PSI Patient Information - OssDsign AB, PDF Ossdsign Cranial Psi Bringing Life to Cranioplasty
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161090 | Class II | Active |
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Manufacturer
- Manufacturer
- Ossdsign AB
Sources (1)
- FDA 510(k) K161090 24 fields · synced Oct 6, 2026