Posifix® Variable Axis Baseplate
FDA UDIEUDAMEDClass II (US FDA UDI)
by Medtec LLC
Identity
- Trade Name
- Posifix® Variable Axis Baseplate FDA UDI
- Generic Name
- Patient positioner base plate FDA UDI
- Device Name
- Posifix® Variable Axis Baseplate FDA UDI
- Model / Reference
- 107065 EUDAMEDFDA UDIHead, Neck, and Shoulder Devices EUDAMED
- Description
- Posifix® Variable Axis Baseplate FDA UDI
Identifiers
- Catalog Number
- 107065 FDA UDI
- Primary DI / UDI-DI
- 00841439110621 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0005R01AQ EUDAMED
- 510(k) Number
- K060737 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient positioner base plate FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Patient positioner base plate
Posifix® Variable Axis Baseplate by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioner base plate.
- Meicen — Guangdong Meicen Medical Equipment Co., Ltd. · Class I
- SRS MR Adapter — Qfix · Class II
- Alta — Qfix · Class II
- Arthrex TRIMANO quick adapter — Maquet, Inc. · Class I
- SRS Adapter — Qfix · Class II
- kVue™ BoS™ — Qfix · Class II
- Adapter TRIMANO FORTIS — Maquet, Inc. · Class I
- TRIMANO FORTIS — Maquet, Inc. · Class I
Cleared under the same submission
K060737 also covers:
- Arm Support — Medtec LLC
- Arm Support — Medtec LLC
- Arm Support — Medtec LLC
- Immobilizer — Medtec LLC
- MR Posi-S™ Adapter — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posifix® -2 Baseplate — Medtec LLC
- Posifix® Headrest — Medtec LLC
- Posifix® Headrest — Medtec LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Medtec LLC
Sources (2)
- FDA UDI ac3b0264-e741-45ba-9987-cb880c3fcdb5 37 fields · synced Jun 19, 2026
- EUDAMED 846b042a-fefd-4f2b-a74a-7a224c60fc69 61 fields · synced Jun 19, 2026