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Driver Assy, 2 prong, For Click'X by Synthes (S9SPINE-CTL - Shukla Spine/ Unive…
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref SDR861Model SDR701
Identity
- Trade Name
- Driver Assy, 2 prong, For Click'X by Synthes (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMED
- Device Name
- Driver Assy, Male, Hex, 2 mm EUDAMED
- Model / Reference
- SDR701 EUDAMEDSDR861 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SDR8610 EUDAMED
- Basic UDI-DI
- ++B756S9SPINECTLSSK3 EUDAMED
- Direct Marketing DI
- +B756SDR8610 EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Driver Assy, 2 prong, For Click'X by Synthes (S9SPINE-CTL - Shukla Spine/ Unive… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — FDA_510K, MDR…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K992739 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++B756S9SPINECTLSSK3 | Class I | Active |
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Manufacturer
- Manufacturer
- S. S. White Technologies Inc/DBA Shukla Medical
- EUDAMED SRN
- US-MF-000007058
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 5ce07b02-d8b6-4f18-b868-143499b7b9c7 61 fields · synced Oct 6, 2026
- FDA 510(k) K992739 1 fields · synced May 18, 2026