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CSF Plus Cancellous Bone Screw 6.5mm Thread Diameter Length 15mm
EUDAMEDClass IIb (EU MDR)
Ref 55-15-02
Identity
- Device Name
- CSF Plus Cancellous Bone Screw 6.5mm Thread Diameter Length 15mm EUDAMED
- Model / Reference
- 55-15-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032982005938 EUDAMED
- Basic UDI-DI
- B-05032982005938 EUDAMED
- EMDN Code
- P09088007 HIP PROSTHESES FIXING SCREWS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
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
Category: Orthopaedic bone screw (non-sliding)
CSF Plus Cancellous Bone Screw 6.5mm Thread Diameter Length 15mm by JRI Orthopaedics Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · 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-05032982005938 | Class IIb | Active |
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Manufacturer
- Manufacturer
- JRI Orthopaedics Ltd
- EUDAMED SRN
- GB-MF-000007529
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED e8ad8fc6-b127-4240-86ac-af0f5ffabc74 61 fields · synced Jun 18, 2026