Identity
- Trade Name
- U-Motion II FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Trial locking screw FDA UDI
- Model / Reference
- 9206-5110 FDA UDI
- Description
- Trial locking screw FDA UDI
Identifiers
- Catalog Number
- 9206-5110 FDA UDI
- Primary DI / UDI-DI
- 04719872143109 FDA UDI
- 510(k) Number
- K122185 FDA UDI
- FDA Product Code
- LZO FDA UDILWJ FDA UDIKWY FDA UDIMEH FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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: Orthopaedic prosthesis implantation positioning instrument, reusable
U-Motion II by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K122185 also covers:
- Ceramic Femoral Head BIOLOX® Delta 12/14S — UNITED ORTHOPEDIC CORP.
- Ti Cancellous Screw — UNITED ORTHOPEDIC CORP.
- U-Motion II — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — 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 bf2e4db5-c38b-4e43-8eda-d87f5a74d23f 36 fields · synced Jun 8, 2026