Identity
- Trade Name
- Navigator CS FDA UDI
- Generic Name
- Patient positioner base plate FDA UDI
- Model / Reference
- 80-500 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365805000 FDA UDI
- 510(k) Number
- K103616 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Patient positioner base plate 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: Patient positioner base plate
Navigator CS by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioner base plate.
- Meicen — Guangdong Meicen Medical Equipment Co., Ltd. · Class I
- Type-S™ Variable Axis Baseplate — Medtec LLC · Class II
- SRS MR Adapter — Qfix · Class II
- Posifix® -2 Baseplate — Medtec LLC · Class II
- Alta — Qfix · Class II
- MR Posi-S™ Adapter — Medtec LLC · Class II
- Uni-frame® Baseplate — Medtec LLC · Class II
- Prone Head Holder — Medtec LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aktina Corp.
Sources (1)
- FDA UDI fea1d7d4-db06-4b7c-8354-fefedf2894b4 33 fields · synced Jun 6, 2026