Delta Xtend

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: DELTA XTEND FDA UDI
Generic Name: Polyethylene reverse shoulder prosthesis cup FDA UDI
Device Name: DELTA Xtend Standard Humeral PE Cup Dia42 /+9mm STD FDA UDI
Model / Reference: 130742209 FDA UDI
Description: DELTA Xtend Standard Humeral PE Cup Dia42 /+9mm STD FDA UDI

Identifiers

Catalog Number: 130742209 FDA UDI
Primary DI / UDI-DI: 10603295027553 FDA UDI
510(k) Number: K062250 FDA UDI
K081620 FDA UDI
K120174 FDA UDI
K192855 FDA UDI
FDA Product Code: KWS FDA UDI
HSD FDA UDI
GMDN Term: Polyethylene reverse shoulder prosthesis cup FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
888.3690 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

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Polyethylene reverse shoulder prosthesis cup

Delta Xtend by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyethylene reverse shoulder prosthesis cup.

PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
FX V135 Shoulder Prosthesis — FX SOLUTIONS · Class II
TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
Equinoxe® — Exactech, Inc. · Class II
Tornier Perform Humeral System — TORNIER, INC. · Class II
PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II

Cleared under the same submission

K062250 also covers:

K081620 also covers:

K120174 also covers:

K192855 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Depuy (ireland)

Sources (1)

FDA UDI 6b3e3293-4a69-463e-b5d9-0757a6c7f5a9 36 fields · synced Jun 6, 2026