HipFix® Baseplate
FDA UDIEUDAMEDClass II (US FDA UDI)
by Medtec LLC
Identity
- Trade Name
- HipFix® Baseplate FDA UDI
- Generic Name
- Radiological pelvis positioner FDA UDI
- Device Name
- HipFix® Baseplate FDA UDI
- Model / Reference
- MTPLVC04MR EUDAMEDFDA UDIBreast and Pelvis EUDAMED
- Description
- HipFix® Baseplate FDA UDI
Identifiers
- Catalog Number
- MTPLVC04MR FDA UDI
- Primary DI / UDI-DI
- 00841439113080 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621BREASTPELVISTG EUDAMED
- 510(k) Number
- K093738 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiological pelvis positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Malta 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: Radiological pelvis positioner
HipFix® Baseplate by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological pelvis positioner.
- Qfix® MRI Pelvis System — Qfix · Class II
- Back/Abdomen SatPad™ — Sat Pad Inc. · Class II
- SofTouch™ — Qfix · Class II
- SofTouch™ Elite — Qfix · Class II
- MEDRAD® PRO-TEKT Endorectal Balloon — Bayer Medical Care Inc. · Class I
- Qfix® Carbon Fiber Pelvis System — Qfix · Class II
- Positioning Cushion — Medtec LLC · Class II
- Belly Board MRI — Medtec LLC · Class II
Cleared under the same submission
K093738 also covers:
- AccuForm™ Cushion — Medtec LLC
- Headrest - TIMO Size A, B, C, F — Medtec LLC
- Headrest - Timo size F with base — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- MR Posi-S™ Adapter — Medtec LLC
- Monarch™ Overhead Arm Positioner — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — 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 74d88696-86a1-457c-b685-a071c1f1ac57 36 fields · synced Jul 21, 2026
- EUDAMED 722773f2-2c2c-402e-902d-0858c4c3150d 61 fields · synced Jul 21, 2026