CoCrMo Alloy Femoral Heads 12/14

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 0524362Model Co-Cr-Mo FEMORAL HEAD CONE 12/14 DIAM 36 MEDIUM

by Adler Ortho Spa

Identity

Trade Name: CO-CR HEADS EUDAMED
CoCrMo Alloy Femoral Heads 12/14 FDA UDI
Generic Name: Metallic femoral head prosthesis FDA UDI
Device Name: CoCrMo Femoral Head Ø36mm (Medium) FDA UDI
Model / Reference: Co-Cr-Mo FEMORAL HEAD CONE 12/14 DIAM 36 MEDIUM EUDAMED
0524362 EUDAMED
Femoral Head FDA UDI
Description: CoCrMo Femoral Head Ø36mm (Medium) FDA UDI

Identifiers

Catalog Number: 0524362 FDA UDI
Primary DI / UDI-DI: 08052532831609 EUDAMEDFDA UDI
Basic UDI-DI: B-08052532831609 EUDAMED
FDA Product Code: LPH FDA UDI
JDI FDA UDI
LZO FDA UDI
MBL FDA UDI
EMDN Code: P090804050202 METAL FEMORAL HEADS, TOTAL HIP REPLACEMENT EUDAMED
GMDN Term: Metallic femoral head prosthesis FDA UDI

Classification

Device Class: Class III EUDAMED
Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
888.3350 FDA UDI
888.3353 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

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

CoCrMo Alloy Femoral Heads 12/14 by Adler Ortho Spa — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Adler Ortho Spa

Sources (2)

FDA UDI b54e1be6-2fb4-473f-9d07-18928f23db83 35 fields · synced Jul 24, 2026
EUDAMED fffc5c6e-3d2b-490a-bdde-5b664b28fd6f 61 fields · synced Jul 24, 2026