Identity
- Trade Name
- U2 Acetabular Components FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Screw set case FDA UDI
- Model / Reference
- 9203-8104 FDA UDI
- Description
- Screw set case FDA UDI
Identifiers
- Catalog Number
- 9203-8104 FDA UDI
- Primary DI / UDI-DI
- 04719872173564 FDA UDI
- 510(k) Number
- K111546 FDA UDI
- FDA Product Code
- JDI FDA UDILPH FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3358 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: Instrument tray, reusable
U2 Acetabular Components 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
K111546 also covers:
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System, Femoral Head — UNITED ORTHOPEDIC CORP.
- U1 Hip System, Femoral Head — UNITED ORTHOPEDIC CORP.
- U1 Hip System, Femoral Head — UNITED ORTHOPEDIC CORP.
- U1™ Hip — UNITED ORTHOPEDIC CORP.
- U2 Acetabular Components — UNITED ORTHOPEDIC CORP.
- U2 Acetabular Components — UNITED ORTHOPEDIC CORP.
- U2 Acetabular Components — UNITED ORTHOPEDIC CORP.
- U2 Acetabular Components — 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 83c64a4e-c712-40ca-bb4c-edc80777a0c4 36 fields · synced May 31, 2026