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Synergy Disc Pin Distractors, Retainers, Caspar Distractors
EUDAMEDClass I (EU MDR)
Ref 1077-5240Model RetainerRef 910-00001Model UDI50014 - Pin Distractor / Retainer
Identity
- Device Name
- Synergy Disc Pin Distractors, Retainers, Caspar Distractors EUDAMEDSynergy Pin Distractor / Retainer EUDAMED
- Model / Reference
- Retainer EUDAMED1077-5240 EUDAMEDUDI50014 - Pin Distractor / Retainer EUDAMED910-00001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++M670UDI50001X3 EUDAMED+M6709100000101 EUDAMED
- Basic UDI-DI
- B-++M670UDI50001X3 EUDAMED++M670UDI50014XC EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMEDL11050199 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
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 Pin Distractors, Retainers, Caspar Distractors by Synergy Spine Solutions Inc. — Class I — MDR, MDD — listed in EUDAMED
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-++M670UDI50001X3 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-++M670UDI50001X3 | 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 (2)
- EUDAMED f2ab2ece-0ade-40cf-aa73-f6f449ee00d7 61 fields · synced Sep 18, 2026
- EUDAMED c2d28b7b-d19f-48bc-bcf9-a7de58f6f271 61 fields · synced Sep 18, 2026