Identity
- Trade Name
- OSSDSIGN Cranial PSI FDA UDI
- Generic Name
- Cranioplasty plate, non-alterable FDA UDI
- Device Name
- OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090) FDA UDI
- Model / Reference
- L FDA UDI
- Description
- OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090) FDA UDI
Identifiers
- Catalog Number
- 101010 FDA UDI
- Primary DI / UDI-DI
- 07350086550108 FDA UDI
- FDA Product Code
- GXN FDA UDI
- GMDN Term
- Cranioplasty plate, non-alterable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5330 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
OSSDSIGN Cranial PSI by Ossdsign AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ossdsign AB
Sources (1)
- FDA UDI b512122c-cbf7-4ddf-8ee9-284b5bb73bc6 36 fields · synced May 30, 2026