← Back to catalogue
Easytech Anatomical Shoulder System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 314-0038
by Fx Solutions
Identity
- Trade Name
- Easytech Anatomical Shoulder System FDA UDI
- Generic Name
- Uncoated shoulder humeral stem prosthesis FDA UDI
- Device Name
- EASYTECH ANCHOR BASE TA6V Ø38 mm CEMENTLESS Ti/HA EUDAMEDFDA UDI
- Model / Reference
- 314-0038 EUDAMEDFDA UDI
- Description
- EASYTECH ANCHOR BASE TA6V Ø38 mm CEMENTLESS Ti/HA FDA UDI
Identifiers
- Catalog Number
- 314-0038 FDA UDI
- Primary DI / UDI-DI
- 03701037301487 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701037301487 EUDAMED
- 510(k) Number
- K201391 FDA UDI
- FDA Product Code
- PKC FDA UDI
- EMDN Code
- P090104010201 EPIPHYSARY HUMERAL COMPONENTS FOR REVERSE PROSTHESES - INSERTS EUDAMED
- GMDN Term
- Uncoated shoulder humeral stem prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3660 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 38 Millimeter FDA UDI
Category: Uncoated shoulder humeral stem prosthesis
Easytech Anatomical Shoulder System by Fx Solutions — Class II — MDD, 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
- Bigliani/Flatow® — Zimmer, Inc. · Class II
- REUNION — Stryker Corp. · Class II
- REUNION — Stryker Corp. · Class II
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Anatomical Shoulder™ — Zimmer, Inc. · Class II
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- SMR System — Limacorporate · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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
- Fx Solutions
Sources (2)
- FDA UDI 3df6faad-c69e-46bf-b461-cfc65aca0960 37 fields · synced Aug 1, 2026
- EUDAMED 99abfc39-3ff9-4a66-8dfc-5edbbe0fe197 61 fields · synced Aug 1, 2026