Identity
- Trade Name
- UTF Hip Stem EUDAMEDUTF™ Stem FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- United Hip and Knee Non-sterile Reusable Instruments EUDAMEDUTF Broach, reduced, #12 FDA UDI
- Model / Reference
- 9106-6312 EUDAMEDFDA UDI
- Description
- UTF Broach, reduced, #12 FDA UDI
Identifiers
- Catalog Number
- 9106-6312 FDA UDI
- Primary DI / UDI-DI
- 04719872157007 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987216TD-Ir-003F4 EUDAMED
- Direct Marketing DI
- 04719872157007 EUDAMED
- 510(k) Number
- K132207 FDA UDI
- FDA Product Code
- LZO FDA UDILPH FDA UDIKWY FDA UDI
- EMDN Code
- L091202 ORTHOPAEDIC SURGERY FILES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic broach FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3358 FDA UDI888.3390 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Moist Heat or Steam Sterilization FDA UDI
UTF Hip Stem by United Orthopedic Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987216TD-Ir-003F4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corporation
- EUDAMED SRN
- TW-MF-000009523
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED a6915f7d-45d4-4548-8d2b-9dc34526a777 61 fields · synced Jul 28, 2026
- FDA UDI 2a0d7c7c-6eba-4973-b5dc-8e73e94a9909 37 fields · synced May 30, 2026