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 body FDA UDI
Device Name: Reverse tray, uncemented, CoCrMo, extended FDA UDI
Model / Reference: 643-010/01 FDA UDI
Description: Reverse tray, uncemented, CoCrMo, extended FDA UDI

Identifiers

Catalog Number: 643-010/01 FDA UDI
Primary DI / UDI-DI: 04026575533657 FDA UDI
510(k) Number: K231445 FDA UDI
FDA Product Code: PAO FDA UDI
PHX FDA UDI
GMDN Term: Reverse shoulder prosthesis body 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 body

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 body.

Duocentric® — Aston Medical · Class II
BIO-MODULAR REVERSE SHOULDER — Biomet Orthopedics, Inc. · Class II
Comprehensive® Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
Identity™ — Zimmer, Inc. · Class II
GLOBAL UNITE — DEPUY (IRELAND) · Class II
Comprehensive Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
Duocentric® — Aston Medical · Class II
Comprehensive® — Zimmer, 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 22e49c1a-8a10-4f56-948a-c515512c54ca 35 fields · synced May 30, 2026