LINK Embrace Shoulder System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- LINK Embrace Shoulder System FDA UDI
- Generic Name
- Coated shoulder humeral stem prosthesis FDA UDI
- Device Name
- LINK Embrace Shoulder System EUDAMEDHumeral Short Stems FDA UDI
- Model / Reference
- 640-175/12 EUDAMEDFDA UDIHumeral stem, CaP coating, uncemented, Ti6Al4V, short EUDAMED
- Description
- Humeral Short Stems FDA UDI
Identifiers
- Catalog Number
- 640-175/12 FDA UDI
- Primary DI / UDI-DI
- 04026575260744 EUDAMEDFDA UDI
- Basic UDI-DI
- 4026575-1-OEX-300034-WS EUDAMED
- 510(k) Number
- K200368 FDA UDI
- FDA Product Code
- PAO FDA UDIPHX FDA UDIHSD FDA UDI
- EMDN Code
- P0901040201 SHOULDER PROSTHESES NON MODULAR STEMS EUDAMED
- GMDN Term
- Coated shoulder humeral stem prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
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: Coated shoulder humeral stem prosthesis
LINK 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 Coated shoulder humeral stem prosthesis.
- OsseoFit™ Stemless Shoulder — Zimmer, Inc. · Class II
- TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- Tornier HRS — TORNIER, INC. · Class II
- Comprehensive® Shoulder System — Biomet Orthopedics, Inc. · Class II
- Trabecular Metal® — Zimmer, Inc. · Class II
- Comprehensive SRS — Biomet Orthopedics, Inc. · Class II
- INHANCE — DEPUY (IRELAND) · Class II
- Aequalis™ PerFORM+ — TORNIER, INC. · Class II
Cleared under the same submission
K200368 also covers:
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG
- LINK 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 93efe8e4-55fb-4121-8685-9871794d23ca 35 fields · synced Oct 7, 2026
- EUDAMED 68f0a5f0-a32a-487b-b63e-71cb58a9a87e 61 fields · synced Oct 7, 2026