LINK Embrace Shoulder System Line Extension

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 643-039/00Model Glenoid insert, uncemented, UHMWPE, reverse

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: LINK Embrace Shoulder System Line Extension FDA UDI
LINK Embrace Shoulder System FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Polyethylene reverse shoulder prosthesis cup FDA UDI
Device Name: LINK Embrace Shoulder System EUDAMED
Bone Screws, and Cortical Bone Screw FDA UDI
Reverse Inserts, neutral, cPE FDA UDI
Model / Reference: 643-039/00 EUDAMEDFDA UDI
Glenoid insert, uncemented, UHMWPE, reverse EUDAMED
645-076/25 FDA UDI
Description: Bone Screws, and Cortical Bone Screw FDA UDI
Reverse Inserts, neutral, cPE FDA UDI

Identifiers

Catalog Number: 645-076/25 FDA UDI
643-039/00 FDA UDI
Primary DI / UDI-DI: 04026575237234 EUDAMEDFDA UDI
04026575533596 FDA UDI
Basic UDI-DI: 4026575-1-OEX-300015-WK EUDAMED
510(k) Number: K231445 FDA UDI
K200368 FDA UDI
FDA Product Code: PAO FDA UDI
PHX FDA UDI
HSD FDA UDI
EMDN Code: P090104010201 EPIPHYSARY HUMERAL COMPONENTS FOR REVERSE PROSTHESES - INSERTS EUDAMED
GMDN Term: Orthopaedic bone screw (non-sliding) FDA UDI
Polyethylene reverse shoulder prosthesis cup FDA UDI

Classification

Device Class: Class III EUDAMED
Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
888.3690 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

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

FDA UDI

Category: Orthopaedic bone screw (non-sliding)

LINK Embrace Shoulder System Line Extension by WALDEMAR LINK GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

EVOS — Smith & Nephew, Inc. · Class II
TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Arthrex® — Arthrex, Inc. · Class II
Zavation — ZAVATION · Class II
STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
Cancellous Screw, Locking — I.T.S. GmbH · Class II
PANGEA — Stryker Corp. · Class II

Cleared under the same submission

K231445 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
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 (3)

FDA UDI 264d37de-e8d8-4d4a-8279-d3a2dae355fe 35 fields · synced Sep 17, 2026
FDA UDI 2f05d248-bc8c-4746-93dc-f9757984aea6 35 fields · synced May 29, 2026
EUDAMED 928b5292-dea2-4148-b1fc-e8bfe4d6cc3b 61 fields · synced Sep 17, 2026