← Back to catalogue

LINK Embrace Shoulder System

FDA UDI

Class II (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name
LINK Embrace Shoulder System FDA UDI
Generic Name
Polyethylene reverse shoulder prosthesis cup FDA UDI
Device Name
Reverse Inserts, inclined 20°, cPE FDA UDI
Model / Reference
643-036/26 FDA UDI
Description
Reverse Inserts, inclined 20°, cPE FDA UDI

Identifiers

Catalog Number
643-036/26 FDA UDI
Primary DI / UDI-DI
04026575238958 FDA UDI
510(k) Number
K200368 FDA UDI
FDA Product Code
HSD FDA UDI
PHX FDA UDI
PAO FDA UDI
GMDN Term
Polyethylene reverse shoulder prosthesis cup FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3690 FDA UDI
888.3660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Polyethylene reverse shoulder prosthesis cup

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

Similar devices

Also classified as Polyethylene reverse shoulder prosthesis cup.

Cleared under the same submission

K200368 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
WALDEMAR LINK GmbH & Co. KG

Sources (1)

  • FDA UDI 329a7fdf-2491-40b8-889e-37408ef9b8e4 35 fields · synced May 31, 2026