Identity
- Trade Name
- Conformity stem, short neck, collared, #2 FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- Conformity stem, short neck, collared, #2 FDA UDI
- Model / Reference
- 1110-1402 FDA UDI
- Description
- Conformity stem, short neck, collared, #2 FDA UDI
Identifiers
- Catalog Number
- 1110-1402 FDA UDI
- Primary DI / UDI-DI
- 04711605583169 FDA UDI
- 510(k) Number
- K183312 FDA UDI
- FDA Product Code
- MEH FDA UDILZO FDA UDI
- GMDN Term
- Metal-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coated hip femur prosthesis, modularMetal-on-polyethylene total hip prosthesisRevision coated hip femur prosthesis
Conformity stem, short neck, collared, #2 by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Revision coated hip femur prosthesis.
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- ZMR® — Zimmer, Inc. · Class II
Cleared under the same submission
K183312 also covers:
- Conformity Stem — UNITED ORTHOPEDIC CORP.
- Conformity Stem — UNITED ORTHOPEDIC CORP.
- Conformity Stem — UNITED ORTHOPEDIC CORP.
- Conformity Stem — UNITED ORTHOPEDIC CORP.
- Conformity stem, #5 — UNITED ORTHOPEDIC CORP.
- Conformity stem, #9 — UNITED ORTHOPEDIC CORP.
- Conformity stem, coxa vara, collared, #2 — UNITED ORTHOPEDIC CORP.
- Conformity stem, high offset, #5 — 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 a5fbb78c-6c39-41d5-853d-61b506e5be89 36 fields · synced May 30, 2026