Fixator™
FDA UDIEUDAMEDClass II (US FDA UDI)
by Medtec LLC
Identity
- Trade Name
- Fixator™ FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Shoulder suppression system with attached strap and thermoplastic frame FDA UDI
- Model / Reference
- MTCFHN006 EUDAMEDFDA UDIHead, Neck, and Shoulder Devices EUDAMED
- Description
- Shoulder suppression system with attached strap and thermoplastic frame FDA UDI
Identifiers
- Catalog Number
- MTCFHN006 FDA UDI
- Primary DI / UDI-DI
- 00841439104125 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0005R01AQ EUDAMED
- 510(k) Number
- K933227 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system 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
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Indexed-immobilization patient positioning system
Fixator™ by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K933227 also covers:
- Fixator™ Shoulder Cups — Medtec LLC
- Headrest — Medtec LLC
- Headrest — Medtec LLC
- Headrest — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- MR Posi-S™ Adapter with Backplate — Medtec LLC
- Prone Face Cushion — Medtec LLC
- Shim — Medtec LLC
- Shim — Medtec LLC
- Swivel Clamp — 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 44e00d13-219e-4bc3-865d-fcf21845fd4e 37 fields · synced Jun 19, 2026
- EUDAMED 80540101-3ea1-4dab-8c08-058c02e80368 61 fields · synced Jun 14, 2026