← Back to catalogue
Orthopaedic Spreader
EUDAMEDClass IIa (EU MDR)
Ref 399.097Model Orthopaedic Spreader
by Synthes GmbH
Identity
- Device Name
- Orthopaedic Spreader EUDAMED
- Model / Reference
- Orthopaedic Spreader EUDAMED399.097 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819220997 EUDAMED
- Basic UDI-DI
- 7611819a00464JW EUDAMED
- Direct Marketing DI
- 07611819220997 EUDAMED
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthopaedic guidewire, reusable
Orthopaedic Spreader by Synthes GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, reusable.
- Guide Wire — I.T.S. GmbH · Class I
- Parallel Wire Guide, for φ2.5 Guide Wire, Adjustable — Double Medical Technology Inc. · Class II
- Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · Class I
- Cosmolock — Kalitec Direct LLC · Class I
- Minuteman — Spinal Simplicity, LLC · Class I
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc. · Class II
- Dyna Locking Trochanteric Nail — CG MedTech Co., Ltd. · Class I
- Made-To-Order — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7611819a00464JW | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Synthes GmbH
- EUDAMED SRN
- CH-MF-000013345
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (1)
- EUDAMED 33ace291-d65c-4dea-b2cf-81f65082bcdc 61 fields · synced Jun 18, 2026