Identity
- Trade Name
- Embrace Shoulder System FDA UDI
- Generic Name
- Uncoated shoulder humeral stem prosthesis FDA UDI
- Model / Reference
- 641-075/17 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04026575234486 FDA UDI
- 510(k) Number
- K212992 FDA UDI
- FDA Product Code
- PAO FDA UDIPHX FDA UDIHSD FDA UDI
- GMDN Term
- Uncoated shoulder humeral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 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
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.
- 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- WALDEMAR LINK GmbH & Co. KG
Sources (1)
- FDA UDI eb75e1dd-2882-405d-a0e0-84049d73d5dc 33 fields · synced May 30, 2026