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Synergy Disc Implant Pilot Cutters
EUDAMEDClass I (EU MDR)
Ref 1077-4440Model Pilot Cutter, SmallRef 910-00010-75Model UDI50021 - Pilot CutterRef 910-00010-76Ref 910-00010-95
Identity
- Device Name
- Synergy Disc Implant Pilot Cutters EUDAMEDSynergy Disc Pilot Cutter EUDAMED
- Model / Reference
- Pilot Cutter, Small EUDAMED1077-4440 EUDAMEDUDI50021 - Pilot Cutter EUDAMED910-00010-75 EUDAMED910-00010-76 EUDAMED910-00010-95 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++M670UDI50009XK EUDAMED+M67091000010750D EUDAMED+M67091000010760E EUDAMED+M67091000010950F EUDAMED
- Basic UDI-DI
- B-++M670UDI50009XK EUDAMED++M670UDI50021X9 EUDAMED
- EMDN Code
- L090901 BONE CUTTERS, REUSABLE 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
CMR Substance
No
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
Synergy Disc Implant Pilot Cutters by Synergy Spine Solutions Inc. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-++M670UDI50009XK | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-++M670UDI50009XK | 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 (4)
- EUDAMED 8fcdd890-6397-4b8a-8012-a74bc0b34fec 61 fields · synced Jul 28, 2026
- EUDAMED 9415061b-a4e6-4445-a892-99a2769c36aa 61 fields · synced Jul 10, 2026
- EUDAMED f912b7ad-3eae-48bb-ace8-a124660d6a63 61 fields · synced Jul 27, 2026
- EUDAMED 1005201b-5e5f-4c62-bdf3-ee9632014848 61 fields · synced Jul 28, 2026