Delta Alumina Ceramic Heads Morse Taper 12/14

FDA UDI

Class II (US FDA UDI)

by Adler Ortho Spa

Identity

Trade Name: Delta Alumina Ceramic Heads Morse Taper 12/14 FDA UDI
Generic Name: Ceramic femoral head prosthesis FDA UDI
Device Name: Delta Alumina Ceramic Head Ø28mm (Medium) FDA UDI
Model / Reference: Femoral Head FDA UDI
Description: Delta Alumina Ceramic Head Ø28mm (Medium) FDA UDI

Identifiers

Catalog Number: 0514282 FDA UDI
Primary DI / UDI-DI: 08052532831241 FDA UDI
FDA Product Code: LPH FDA UDI
JDI FDA UDI
LZO FDA UDI
MBL FDA UDI
GMDN Term: Ceramic femoral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
888.3350 FDA UDI
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

FDA UDI

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: Ceramic femoral head prosthesis

Delta Alumina Ceramic Heads Morse Taper 12/14 by Adler Ortho Spa — 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
SYNERGY — Smith & Nephew, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II

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: Adler Ortho Spa

Sources (1)

FDA UDI 8bcc1dcf-68bd-47f7-ae01-1fc358ba64d4 35 fields · synced May 30, 2026