Identity
- Trade Name
- Embrace Shoulder System FDA UDI
- Generic Name
- Shoulder humeral body prosthesis FDA UDI
- Model / Reference
- 641-040/14 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04026575234363 FDA UDI
- 510(k) Number
- K212992 FDA UDI
- FDA Product Code
- PAO FDA UDIHSD FDA UDIPHX FDA UDI
- GMDN Term
- Shoulder humeral body 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Shoulder humeral body 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 Shoulder humeral body prosthesis.
- Equinoxe — Exactech, Inc. · Class II
- Anatomical Shoulder™ Domelock® — Zimmer, Inc. · Class II
- HemiCAP® — ARTHROSURFACE INCORPORATED · Class II
- Humeris Shoulder — FX SOLUTIONS · Class II
- OVOMotion™ — ARTHROSURFACE INCORPORATED · Class II
- HemiCAPOVO® — ARTHROSURFACE INCORPORATED · Class II
- Equinoxe — Exactech, Inc. · Class II
- GLOBAL UNITE — DEPUY (IRELAND) · 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 |
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Manufacturer
- Manufacturer
- WALDEMAR LINK GmbH & Co. KG
Sources (1)
- FDA UDI 698c5d90-c6a7-4e65-a4bd-d5ce8bc9dcb9 33 fields · synced Jun 1, 2026