Identity
- Trade Name
- U2 Hip Stem FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- U2 Broach, #6 FDA UDI
- Model / Reference
- 9104-6060-RA FDA UDI
- Description
- U2 Broach, #6 FDA UDI
Identifiers
- Catalog Number
- 9104-6060-RA FDA UDI
- Primary DI / UDI-DI
- 04719872167051 FDA UDI
- 510(k) Number
- K003237 FDA UDI
- FDA Product Code
- MEH FDA UDILPH FDA UDI
- GMDN Term
- Orthopaedic broach FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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: Orthopaedic broach
U2 Hip Stem by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic broach.
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Cleared under the same submission
K003237 also covers:
- U2 Hip Stem — UNITED ORTHOPEDIC CORP.
- U2 Hip Stem — UNITED ORTHOPEDIC CORP.
- U2 Hip Stem — UNITED ORTHOPEDIC CORP.
- U2 Hip Stem — UNITED ORTHOPEDIC CORP.
- U2 Hip Stem — UNITED ORTHOPEDIC CORP.
- U2 Hip Stem — UNITED ORTHOPEDIC CORP.
- U2 Hip Stem — UNITED ORTHOPEDIC CORP.
- U2 Hip Stem — UNITED ORTHOPEDIC CORP.
- U2 Hip Stem — UNITED ORTHOPEDIC CORP.
- U2 Hip Stem — UNITED ORTHOPEDIC CORP.
- U2 Hip Stem — UNITED ORTHOPEDIC CORP.
- U2 Hip Stem — 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 c1d3aaf8-e577-4ad4-a1e6-3580ef01bd29 37 fields · synced May 30, 2026