← Back to catalogue
CSF Plus Cancellous Bone Screw 6.5mm Thread Diameter Length 35mm
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 55-35-02Ref 55-45-02Ref 55-20-02Ref 55-50-02
Identity
- Device Name
- CSF Plus Cancellous Bone Screw 6.5mm Thread Diameter Length 35mm EUDAMEDCSF Plus Cancellous Bone Screw 6.5mm Thread Diameter Length 45mm EUDAMEDCSF Plus Cancellous Bone Screw 6.5mm Thread Diameter Length 20mm EUDAMEDCSF Plus Cancellous Bone Screw 6.5mm Thread Diameter Length 50mm EUDAMED
- Model / Reference
- 55-35-02 EUDAMED55-45-02 EUDAMED55-20-02 EUDAMED55-50-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032982006034 EUDAMED05032982006102 EUDAMED05032982005945 EUDAMED05032982006133 EUDAMED
- Basic UDI-DI
- B-05032982006034 EUDAMEDB-05032982006102 EUDAMEDB-05032982005945 EUDAMEDB-05032982006133 EUDAMED
- EMDN Code
- P09088007 HIP PROSTHESES FIXING SCREWS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDSpain 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 35mm by JRI Orthopaedics Ltd — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- 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 (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011719 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-05032982006034 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- JRI Orthopaedics Ltd
- EUDAMED SRN
- GB-MF-000007529
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (5)
- EUDAMED e898b32f-22bf-4b17-826e-b1818b3b815c 61 fields · synced Jul 23, 2026
- EUDAMED 195cd659-5a81-422b-99da-23fcb25621f5 61 fields · synced May 17, 2026
- EUDAMED fc88855e-e86f-45ae-9f8e-770bd3258a48 61 fields · synced May 18, 2026
- EUDAMED e8fd6fd0-399e-4671-908a-eb9b7b05cb10 61 fields · synced May 19, 2026
- FDA 510(k) K011719 1 fields · synced May 18, 2026