Embrace Shoulder System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Embrace Shoulder System FDA UDI
- Generic Name
- Uncoated shoulder humeral stem prosthesis FDA UDI
- Device Name
- LINK Embrace Shoulder System EUDAMED
- Model / Reference
- 641-105/15 EUDAMEDFDA UDIHumeral stem, polished, cemented, Ti6Al4V, modular, revision EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04026575234578 EUDAMEDFDA UDI
- Basic UDI-DI
- 4026575-1-OEX-300038-X6 EUDAMED
- 510(k) Number
- K212992 FDA UDI
- FDA Product Code
- HSD FDA UDIPAO FDA UDIPHX FDA UDI
- EMDN Code
- P0901040204 SHOULDER PROSTHESES REVISION STEMS EUDAMED
- GMDN Term
- Uncoated shoulder humeral stem prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3690 FDA UDI888.3660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Uncoated shoulder humeral stem prosthesis
Embrace Shoulder System by WALDEMAR LINK GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated shoulder humeral stem prosthesis.
- Anatomical Shoulder™ — Zimmer, Inc. · Class II
- Humelock II Cemented Shoulder System — FX SOLUTIONS · Class II
- Bigliani/Flatow® — Zimmer, Inc. · Class II
- REUNION — Stryker Corp. · Class II
- REUNION — Stryker Corp. · Class II
- Anatomical Shoulder™ — Zimmer, Inc. · Class II
- SMR System — Limacorporate · Class II
- REUNION — Stryker Corp. · Class II
Cleared under the same submission
K212992 also covers:
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 (2)
- FDA UDI 94218beb-7ff3-4081-84c5-f2eb7cdbe31f 33 fields · synced Oct 7, 2026
- EUDAMED 42a6652e-86ff-443e-8fbc-aed9f8435cc8 61 fields · synced Oct 7, 2026