Screw driver 3.5 mm – Screw driver (3 mm)

The Screw driver 3.5 mm – Screw driver is a precision bone surgery instrument manufactured by Fizza Surgical for use in orthopedic, trauma, and bone surgery procedures. Designed for fracture…

MOQ: 50 pieces
Lead time: 18–22 working days
Sample order: 10 units · sample fee credited against first PO
OEM private label: Private-label from 300 units per SKU
Materials: AISI 440 / 17-4 PH precipitation-hardened stainless steel
Sterilization: Steam autoclave to 134 °C · EtO compatible
Certifications: ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered
Shipping: DHL Express · UPS · FedEx · sea freight · all Incoterms

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SKU AO 14-295-01 Categories ,
Regulatory Nomenclature
EMDN (EUDAMED): V02050115
GMDN Code: 47603
Orthopedic screwdriver

The Screw driver 3.5 mm – Screw driver (3 mm) (SKU AO 14-295-01) is part of the Fizza Surgical catalogue.

Modern orthopaedic surgery is increasingly implant-centric — and the instrument system reflects that. Plate and screw fixation requires drill guides matched to specific screw diameters, depth gauges for cortical-screw selection, screwdrivers in the proprietary heads each implant manufacturer specifies (hex, Phillips, Torx, Stardrive), taps matched to thread profiles, and trial reduction instruments for implant sizing. Joint arthroplasty extends the instrument family to broaches, rasps, impactors, and component-specific insertion tools. The surgical instrument industry has converged on the patterns and dimensions specified by the major implant manufacturers, and Fizza supplies both standard orthopaedic patterns and OEM-customized variants matched to specific implant systems under ISO 13485:2016.

Reference / SKU AO 14-295-01
Working length 3 mm (0.3 cm)
Material AISI 440 / 17-4 PH precipitation-hardened stainless steel
Sterilization Steam autoclave to 134 °C · EtO compatible
Quality system ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered

Manufacturing compliance is verified through ISO 13485:2016 certification (the international medical-device quality standard), CE marking under EU MDR 2017/745, and FDA establishment registration. Certificate copies and regulatory documentation are available on request for inclusion in hospital procurement files and EU technical documentation packages. Sterilization validation follows ISO 17665 for steam autoclave at 134 °C.

Which orthopedic procedures are your bone-surgery instruments designed for?
General orthopedic surgery, ORIF (Open Reduction Internal Fixation), spinal surgery, joint replacement, trauma surgery, and veterinary orthopedic applications. Catalogue includes bone holding forceps, cutters, gouges, chisels, ronguers, periosteal elevators, and rasps.
What stainless steel grade is used for bone-surgery instruments?
AISI 440 or 17-4 PH (precipitation-hardened) stainless steel for high-stress instruments such as bone cutters, gouges, and chisels. Tungsten-carbide inserts on instrument tips where additional edge retention is required.
Are bone-surgery instruments compatible with steam autoclave sterilization?
Yes — all bone-surgery instruments are designed for repeat steam autoclave cycles at 134 °C and are also EtO compatible. Tungsten-carbide inserts are autoclave-safe.
What is the MOQ for orthopedic instrument private-label?
Standard MOQ is 300 units per SKU for catalogue items, or 50 sets for complete orthopedic kits. Custom designs require 500 units per SKU minimum.

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