Identity
- Trade Name
- USTAR II Knee System FDA UDI
- Generic Name
- Knee tibia prosthesis trial, reusable FDA UDI
- Device Name
- USTAR II Tibial baseplate trial, #6 FDA UDI
- Model / Reference
- 2215-2460 FDA UDI
- Description
- USTAR II Tibial baseplate trial, #6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711605588096 FDA UDI
- 510(k) Number
- K190100 FDA UDI
- FDA Product Code
- KWL FDA UDILWJ FDA UDILPH FDA UDIKRO FDA UDI
- GMDN Term
- Knee tibia prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 FDA UDI888.3358 FDA UDI888.3510 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: Knee tibia prosthesis trial, reusable
USTAR II Knee System 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
K190100 also covers:
- "UNITED" USTAR II Hip System — UNITED ORTHOPEDIC CORP.
- "UNITED" USTAR II Knee System — UNITED ORTHOPEDIC CORP.
- "UNITED" USTAR II Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- USTAR II Knee System — UNITED ORTHOPEDIC CORP.
- USTAR II Knee System — UNITED ORTHOPEDIC CORP.
- USTAR II Knee System — 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 60e1cf40-5a08-4102-b1a6-6666ee0a0d8b 35 fields · synced May 31, 2026