Identity
- Trade Name
- PositionPro Head Cradle FDA UDI
- Generic Name
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
- Model / Reference
- 50-855 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365508550 FDA UDI
- 510(k) Number
- K103616 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stereotactic radiosurgical/radiotherapy arch head frame
PositionPro Head Cradle by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stereotactic radiosurgical/radiotherapy arch head frame.
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- BodyFIX — 3C-Medical Intelligence GmbH · Class II
- Bite Cup — Medtec LLC · Class II
- Fraxion — 3C-Medical Intelligence GmbH · Class II
- Fraxion — 3C-Medical Intelligence GmbH · Class II
- Fraxion — 3C-Medical Intelligence GmbH · Class II
- trUpoint ARCH™ — Medtec LLC · Class II
Cleared under the same submission
K103616 also covers:
- Adjustable Knee Support — Aktina Corp.
- Arch Kit, PositionPro — Aktina Corp.
- ArmAssist, PositionPro — Aktina Corp.
- Carbon Fiber Base Board, Head and Neck — Aktina Corp.
- Carbon Fiber Base Board, Long — Aktina Corp.
- Carbon Fiber Board, Short — Aktina Corp.
- Carbon Fiber Head Cradle Assembly — Aktina Corp.
- Cranial Localizer, Non-Stereotactic — Aktina Corp.
- Cranial Stereotactic Localizer Frame — Aktina Corp.
- Crossbar Assembly — Aktina Corp.
- Crossbar Assembly — Aktina Corp.
- Foot Stabilizer — Aktina Corp.
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
- Aktina Corp.
Sources (1)
- FDA UDI 05482b14-77b7-4538-8114-2f852c8ed9fd 33 fields · synced Jun 1, 2026