Identity
- Trade Name
- Fraxion FDA UDI
- Generic Name
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
- Device Name
- FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatment table. FDA UDI
- Model / Reference
- P10106-120 FDA UDI
- Description
- FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatment table. FDA UDI
Identifiers
- Catalog Number
- P10106-120 FDA UDI
- Primary DI / UDI-DI
- 04056719001452 FDA UDI
- 510(k) Number
- K112210 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stereotactic radiosurgical/radiotherapy arch head frame
Fraxion by 3C-Medical Intelligence GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stereotactic radiosurgical/radiotherapy arch head frame.
- Arch Kit, PositionPro — Aktina Corp. · Class II
- Nasion Cushion — Medtec LLC · Class II
- ShoulderAssist, PositionPro — Aktina Corp. · Class II
- PinPoint Arch Support, Extended — Aktina Corp. · Class II
- PinPoint Radiosurgery Immobilization System, Elekta Compatible — Aktina Corp. · Class II
- Carbon Fiber Board, Short — Aktina Corp. · Class II
- PinPoint Mouthpiece Assembly, Medium — Aktina Corp. · Class II
- PositionPro Head Cradle — Aktina Corp. · Class II
Cleared under the same submission
K112210 also covers:
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
- 3C-Medical Intelligence GmbH
Sources (1)
- FDA UDI c159af26-ccd7-4b82-afb0-64a1f4e44809 35 fields · synced Jun 1, 2026