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SYNTHESIS Stem: Trial Cone Mark S - Size 5-11, 25 - Offset B
EUDAMEDClass IIa (EU MDR)
Ref S14122Ref S14121
Identity
- Trade Name
- SYNTHESIS Stem: Trial Cone Mark S - Size 5-11,25 - Offset B EUDAMEDSYNTHESIS Stem: Trial Cone Mark S - Size 5-11,25 - Offset A EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S14122 EUDAMEDS14121 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323060856 EUDAMED08050323060849 EUDAMED
- Basic UDI-DI
- B-08050323060856 EUDAMEDB-08050323060849 EUDAMED
- EMDN Code
- V06010101 HIP PROSTHESES TESTING DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Acetabulum prosthesis trial, prefabricated, reusable
SYNTHESIS Stem: Trial Cone Mark S - Size 5-11, 25 - Offset B by Permedica S.p.A — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Acetabulum prosthesis trial, prefabricated, reusable.
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- Novation — Exactech, Inc. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class II
- MultiPolar® — Zimmer, Inc. · Class I
- Continuum® Trilogy® — Zimmer, Inc. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08050323060856 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (2)
- EUDAMED 6a619ae4-f410-470f-b6d7-7e933aae0975 61 fields · synced Jul 26, 2026
- EUDAMED 1f711dd9-7876-4278-b371-8d6fac111f57 61 fields · synced May 17, 2026