Femoral Head

FDA UDI

Class II (US FDA UDI)

by Fournitures Hospitalieres Industrie

Identity

Trade Name: Femoral Head FDA UDI
Generic Name: Metallic femoral head prosthesis FDA UDI
Model / Reference: 240865 - 12/14 TAPER CoCr HEAD, Ø28 / L(+7) FDA UDI

Identifiers

Primary DI / UDI-DI: 03661489408656 FDA UDI
510(k) Number: K021109 FDA UDI
FDA Product Code: LPH FDA UDI
GMDN Term: Metallic 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

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Metallic femoral head prosthesis

Femoral Head by Fournitures Hospitalieres Industrie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic femoral head prosthesis.

Normmed CoCr Femoral Head 28 +12 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class III
Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
Orthinox — Howmedica Osteonics Corp. · Class II
Orthinox — Howmedica Osteonics Corp. · Class II
A110212031 — EUROS SAS · Class III
Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II

Cleared under the same submission

K021109 also covers:

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: Fournitures Hospitalieres Industrie

Sources (1)

FDA UDI 439347f1-7348-43b9-8d29-47d43c88f9f6 33 fields · synced May 30, 2026