Identity
- Trade Name
- LINK Embrace Shoulder System FDA UDI
- Generic Name
- Total shoulder prosthesis FDA UDI
- Device Name
- Humeral Head FDA UDI
- Model / Reference
- 642-038/12 FDA UDI
- Description
- Humeral Head FDA UDI
Identifiers
- Catalog Number
- 642-038/12 FDA UDI
- Primary DI / UDI-DI
- 04026575236138 FDA UDI
- 510(k) Number
- K210899 FDA UDI
- FDA Product Code
- PAO FDA UDIHSD FDA UDIKWS FDA UDIKWT FDA UDI
- GMDN Term
- Total shoulder prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 FDA UDI888.3650 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: Total shoulder 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 Total shoulder prosthesis.
- B-P TOTAL SHOULDER SYSTEM — ENDOTEC, INC. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- Shoulder Innovations Humeral Stemless System — SHOULDER INNOVATIONS, Inc · Class II
- Shoulder Innovations Inset Reverse Total Shoulder — SHOULDER INNOVATIONS, Inc · Class II
- Shoulder System — Medacta International · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- Arthrex® — Arthrex, Inc. · Class II
Cleared under the same submission
K210899 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 (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 f367b991-19ab-4b8f-8066-fe2e5e63e606 35 fields · synced Jun 1, 2026