Identity
- Trade Name
- Conquest FX FDA UDI
- Generic Name
- Ceramic femoral head prosthesis FDA UDI
- Device Name
- CONQUEST FX FEMORAL COMPONENT SIZE 18 FDA UDI
- Model / Reference
- 71316518 FDA UDI
- Description
- CONQUEST FX FEMORAL COMPONENT SIZE 18 FDA UDI
Identifiers
- Catalog Number
- 71316518 FDA UDI
- Primary DI / UDI-DI
- 03596010443175 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Ceramic femoral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 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: Ceramic femoral head prosthesis
Conquest FX by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ceramic femoral head prosthesis.
- Ceramic ball head — Beijing LiDaKang Technology Co., Ltd. · Class III
- ELEC(R)plus — HiPer Medical AG · Class III
- BIOLOX® delta Modular Ceramic Head — Biomet Uk Ltd · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- BENCOX Hip System — Corentec Co., Ltd · Class II
Cleared under the same submission
K211176 also covers:
- BUCK — Smith & Nephew, Inc.
- Contour — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- R3 — Smith & Nephew, Inc.
K963509 also covers:
- Conquest FX — Smith & Nephew, Inc.
- Conquest FX — Smith & Nephew, Inc.
- Conquest FX — Smith & Nephew, Inc.
- SYNERGY — Smith & Nephew, Inc.
- SYNERGY — Smith & Nephew, Inc.
- SYNERGY — Smith & Nephew, Inc.
- SYNERGY — Smith & Nephew, Inc.
- SYNERGY — Smith & Nephew, Inc.
- SYNERGY — Smith & Nephew, Inc.
- SYNERGY — Smith & Nephew, Inc.
- SYNERGY — Smith & Nephew, Inc.
- SYNERGY — Smith & Nephew, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI e4760e86-7476-4088-b0ec-2cbb61260869 37 fields · synced Jun 8, 2026