Identity
- Trade Name
- ACORN: Trial insert Ø 28mm for Cup Ø 60mm EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S38860 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323059485 EUDAMED
- Basic UDI-DI
- B-08050323059485 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
ACORN: Trial insert Ø 28mm for Cup Ø 60mm 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.
- Trabecular Metal® — Zimmer, Inc. · Class I
- G7 PROVISIONAL SHELL — Biomet Orthopedics, Inc. · Class II
- Bipolar Head — Limacorporate · Class II
- Acetabular Cups — Limacorporate · Class II
- 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-08050323059485 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (2)
- EUDAMED a315b6fa-9fcd-4974-97b4-e8524098d3af 61 fields · synced Jul 21, 2026
- EUDAMED 566bdfe5-264e-44b1-875d-3d12f68b25f2 61 fields · synced Jul 21, 2026