← 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
Uncoated shoulder humeral stem prosthesis FDA UDI
Device Name
Humeral Standard Stems FDA UDI
Model / Reference
640-100/12 FDA UDI
Description
Humeral Standard Stems FDA UDI

Identifiers

Catalog Number
640-100/12 FDA UDI
Primary DI / UDI-DI
04026575164325 FDA UDI
510(k) Number
K200368 FDA UDI
FDA Product Code
HSD FDA UDI
PHX FDA UDI
PAO FDA UDI
GMDN Term
Uncoated shoulder humeral stem prosthesis 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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Uncoated shoulder humeral stem prosthesis

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 Uncoated shoulder humeral stem prosthesis.

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 101e0cb2-1f09-4983-bd8f-e77190c9441e 35 fields · synced May 30, 2026