LINK Embrace Shoulder System Line Extension

FDA UDI

Class II (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: LINK Embrace Shoulder System Line Extension FDA UDI
Generic Name: Reverse shoulder prosthesis head FDA UDI
Device Name: Glenosphere, uncemented, CoCrMo, lateralized, reverse FDA UDI
Model / Reference: 646-039/04 FDA UDI
Description: Glenosphere, uncemented, CoCrMo, lateralized, reverse FDA UDI

Identifiers

Primary DI / UDI-DI: 04026575533404 FDA UDI
510(k) Number: K231445 FDA UDI
FDA Product Code: PHX FDA UDI
PAO FDA UDI
GMDN Term: Reverse shoulder prosthesis head FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Reverse shoulder prosthesis head

LINK Embrace Shoulder System Line Extension by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reverse shoulder prosthesis head.

Equinoxe — Exactech, Inc. · Class II
Equinoxe — Exactech, Inc. · Class II
SMR System — Limacorporate · Class II
SMR Shoulder — Limacorporate · Class II
JARVIS Glenoid Rerverse Shoulder Prosthesis — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
Trabecular Metal Reverse Plus™ — Zimmer, Inc. · Class II
AGILON® XO glenosphere neutral incl. screw — implantcast GmbH · Class II
TORNIER PERFORM™ REVERSED — TORNIER, INC. · Class II

Cleared under the same submission

K231445 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: WALDEMAR LINK GmbH & Co. KG

Sources (1)

FDA UDI 944376e9-e7dd-4181-95bf-74c3a9c02dea 34 fields · synced May 30, 2026