Identity
- Trade Name
- U-Motion II FDA UDI
- Generic Name
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
- Device Name
- Acetabular cup trial, 53mm FDA UDI
- Model / Reference
- 1306-2053 FDA UDI
- Description
- Acetabular cup trial, 53mm FDA UDI
Identifiers
- Catalog Number
- 1306-2053 FDA UDI
- Primary DI / UDI-DI
- 04719872143062 FDA UDI
- 510(k) Number
- K172833 FDA UDI
- FDA Product Code
- MEH FDA UDIJDI FDA UDILWJ FDA UDIKWY FDA UDIOQI FDA UDILZO FDA UDI
- GMDN Term
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3350 FDA UDI888.3360 FDA UDI888.3390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Acetabulum prosthesis trial, prefabricated, reusable
U-Motion II by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabulum prosthesis trial, prefabricated, reusable.
- Trabecular Metal® — Zimmer, Inc. · Class I
- G7 PROVISIONAL SHELL — Biomet Orthopedics, Inc. · Class II
- Bipolar Head — Limacorporate · Class II
- Acetabular Cups — Limacorporate · Class II
- Novation — Exactech, Inc. · Class I
- TRIAL NECK for Exacta S Rasp - Mark S - Standard — Permedica S.p.A · Class IIa
- INSTRUMENT — Howmedica Osteonics Corp. · Class II
- MultiPolar® — Zimmer, Inc. · Class I
Cleared under the same submission
K172833 also covers:
- E-XPE Cemented cup — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II HA Cup, Cluster-Hole — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II HA Cup, Cluster-Hole — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II HA Cup, Cluster-Hole — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II HA Cup, Multi-Hole — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II HA Cup, No-Hole — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II HA Cup, No-Hole — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II PS Cup, Cluster-Hole — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II PS Cup, Cluster-Hole — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II PS Cup, Cluster-Hole — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II PS Cup, Multi-Hole — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II PS Cup, Multi-Hole — UNITED ORTHOPEDIC CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (1)
- FDA UDI f08c2ca3-9c12-4ca7-820e-6e9cdf70d5aa 36 fields · synced May 31, 2026