Driver 4 prong, for Pass LP Nut by Medicrea (S9SPINE-CTL - Shukla Spine/ Univer…
EUDAMEDFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- Driver 4 prong, for Pass LP Nut by Medicrea (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMED
- Device Name
- Driver Assy, Male, Hex, 2 mm EUDAMED
- Model / Reference
- SDR701 EUDAMEDSDR882 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SDR8820 EUDAMED
- Basic UDI-DI
- ++B756S9SPINECTLSSK3 EUDAMED
- Direct Marketing DI
- +B756SDR8820 EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
This device is a Driver Assembly, Male Hex, 2 mm, classified under nomenclature code L26 as part of the Shukla Spine Universal Spinal Screw Removal System. It is designed as a reusable orthopedic tool for engaging and removing spinal screws, particularly those secured with Pass LP nuts, in spinal surgical procedures. The hex-shaped driver interface ensures precise torque application to facilitate screw extraction without additional bone trauma.
The Driver Assembly is intended for reusable clinical use and is not sterile or implantable. It is supplied as part of the S9SPINE-CTL system (Model SDR701) and carries a Basic UDI: ++B756S9SPINECTLSSK3. Authorized under FDA 510K clearance (K100297) and MDR compliance, this tool adheres to orthopedic surgical standards without latex components or animal-derived materials. Storage and reprocessing follow manufacturer guidelines to maintain sterility and functionality for repeated use.
Frequently asked questions
What is the primary purpose of this Driver Assembly in spinal surgery?
This Driver Assembly is a reusable orthopedic tool designed specifically for engaging and removing spinal screws that are secured with Pass LP nuts during spinal surgical procedures. Its hex-shaped design ensures precise torque application, helping to extract screws efficiently while minimizing additional bone trauma.
Is this driver meant for single-use or repeated clinical use?
This Driver Assembly is explicitly designed for reusable clinical use. It is part of the S9SPINE-CTL system (Model SDR701) and must be reprocessed according to manufacturer guidelines to maintain functionality and sterility for multiple procedures.
What size and type of driver interface does this tool feature, and how does it differ from standard hex drivers?
This tool features a male hex driver interface with a 2 mm shank, optimized for compatibility with Pass LP nuts. Unlike standard hex drivers, its four-prong design provides a secure grip on the screw head, ensuring precise torque application and reducing slippage during removal.
How is this device supplied, and what should clinicians know about its sterility and packaging?
The Driver Assembly is supplied as part of the S9SPINE-CTL system (Model SDR701) and is not sterile out-of-the-box. Since it is reusable, it must be cleaned and reprocessed per manufacturer instructions before each use. The system includes the driver as a non-sterile component for clinical reprocessing.
What regulatory pathways does this device follow, and who authorized its market introduction?
This device was authorized under FDA 510(k) clearance (K100297) with a decision labeled *Substantially Equivalent* (SESE) and is also compliant with the EU MDR (Medical Device Regulation). The applicant was Medicrea Technologies, and the manufacturer is S. S. White Technologies Inc/DBA Shukla Medical, ensuring adherence to orthopedic surgical standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Shukla Medical - Spine, Driver Center - Ihr Autoservice und Reifenspezialist, S. S. White Technologies Inc/DBA Shukla Medical - BEUDAMED, Shukla Medical - Screw, PDF Shukla Medical
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083810 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K100297 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K083308 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K080099 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K082577 | 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 ef47fe9c-1040-4fed-89fb-ec079a6a6972 61 fields · synced Oct 7, 2026
- FDA 510(k) K083810 1 fields · synced May 18, 2026