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Synergy Disc Distractors, Intervertebral Distractors, Paddle Spreaders
EUDAMEDClass I (EU MDR)
Ref 1077-5170Model Distractor
Identity
- Device Name
- Synergy Disc Distractors, Intervertebral Distractors, Paddle Spreaders EUDAMED
- Model / Reference
- Distractor EUDAMED1077-5170 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++M670UDI50006XD EUDAMED
- Basic UDI-DI
- B-++M670UDI50006XD EUDAMED
- EMDN Code
- L11050199 VERTEBRAL SURGERY SPREADERS AND RETRACTORS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Synergy Disc Distractors, Intervertebral Distractors, Paddle Spreaders by Synergy Spine Solutions Inc. — Class I — MDD — listed in EUDAMED
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-++M670UDI50006XD | Class I | Active |
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Manufacturer
- Manufacturer
- Synergy Spine Solutions Inc.
- EUDAMED SRN
- US-MF-000014165
- Authorised Representative
- MedNet EC-REP III GmbH DE-AR-000011191
Sources (1)
- EUDAMED c8eaf9f9-e1cd-4146-b5de-3a1febd12e0c 61 fields · synced Jul 22, 2026