Identity
- Trade Name
- UTS Hip Stem FDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- UTS Neck trial, high offset, #5~#6 FDA UDI
- Model / Reference
- 9116-5221-TD FDA UDI
- Description
- UTS Neck trial, high offset, #5~#6 FDA UDI
Identifiers
- Catalog Number
- 9116-5221-TD FDA UDI
- Primary DI / UDI-DI
- 04719886903959 FDA UDI
- 510(k) Number
- K172251 FDA UDI
- FDA Product Code
- LPH FDA UDILZO FDA UDIKWY FDA UDI
- GMDN Term
- Femoral stem prosthesis trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 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: Femoral stem prosthesis trial
UTS Hip Stem 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
K172251 also covers:
- UTS Hip Stem — UNITED ORTHOPEDIC CORP.
- UTS Hip Stem — UNITED ORTHOPEDIC CORP.
- UTS Hip Stem — UNITED ORTHOPEDIC CORP.
- UTS Hip Stem — UNITED ORTHOPEDIC CORP.
- UTS Hip Stem — UNITED ORTHOPEDIC CORP.
- UTS Hip Stem — UNITED ORTHOPEDIC CORP.
- UTS Hip Stem — UNITED ORTHOPEDIC CORP.
- UTS Stem, Ti plasma spray — UNITED ORTHOPEDIC CORP.
- UTS Stem, Ti plasma spray, high offset — 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 3cc79bcc-03b0-4a22-a81f-c6e930325976 36 fields · synced May 31, 2026