Identity
- Trade Name
- U-Motion II EUDAMEDFDA UDI
- Generic Name
- Femoral head prosthesis trial FDA UDI
- Device Name
- Ceramic femoral head trial, Delta, Ø28mm, S, -2.5mm EUDAMEDFDA UDI
- Model / Reference
- 1203-6028-RC EUDAMEDFDA UDI
- Description
- Ceramic femoral head trial, Delta, Ø28mm, S, -2.5mm FDA UDI
Identifiers
- Catalog Number
- 1203-6028-RC FDA UDI
- Primary DI / UDI-DI
- 04711605586658 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04711605586658 EUDAMED
- 510(k) Number
- K103497 FDA UDI
- FDA Product Code
- MEH FDA UDILWJ FDA UDILPH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Femoral head prosthesis trial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3360 FDA UDI888.3358 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Category: Femoral head prosthesis trial
U-Motion II by United Orthopedic Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Femoral head prosthesis trial.
- BI-METRIC(R) HEAD/NECK PROVISIONAL — Biomet Orthopedics, Inc. · Class I
- Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
- CHARNLEY — DEPUY INTERNATIONAL LTD · Class I
- Klassic Femoral Head Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- AcuMatch — Exactech, Inc. · Class I
- G7® — Biomet Orthopedics, Inc. · Class II
- AcuMatch — Exactech, Inc. · Class I
- NovoHip Total Hip System — Novosource, Inc. · Class II
Cleared under the same submission
K103497 also covers:
- Ceramic Femoral Head BIOLOX® Delta 12/14L — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14L — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14M — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14M — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14S — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14S — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14XL — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Forte 12/14L — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Forte 12/14L — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Forte 12/14M — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Forte 12/14M — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Forte 12/14S — UNITED ORTHOPEDIC CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (2)
- FDA UDI 3a597641-4320-4287-aedc-0c0a8b7c6553 36 fields · synced Oct 9, 2026
- EUDAMED 982dcc31-7a2e-4045-9e2d-f659f7d4e649 61 fields · synced Oct 9, 2026