LUCAS x =5 mm, Chisel 160mm 16cm (Ref BS 14-210-03)

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LUCAS x =5 mm, Chisel 160mm 16cm BONE SURGERY- BONE CHISELS AND GOUGES

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 420 / AISI 440 / 17-4 PH stainless steel · tungsten-carbide inserts where applicable
Sterilization: Steam autoclave to 134 °C · EtO compatible
Certifications: ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA-registered
Shipping: DHL Express · UPS · FedEx · sea freight · all Incoterms

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SKU BS 14-210-03 Category
Regulatory Nomenclature
EMDN (EUDAMED): V0205
GMDN Code: 35275
Bone surgery instrument
Reference / SKUBS 14-210-03
Working length5 mm (0.5 cm)
MaterialAISI 440 / 17-4 PH precipitation-hardened stainless steel
SterilizationSteam autoclave to 134 °C · EtO compatible
Quality systemISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered

LUCAS x =5 mm, Chisel 160mm 16cm (Ref BS 14-210-03), supplied from Fizza Surgical’s instrument range under ISO 13485:2016 quality management.

Cortical bone delivers a mechanical challenge that soft-tissue instruments aren’t designed for: hardness, density, and the requirement to cut, hold, or displace without instrument deformation. Bone-cutting forceps (Liston, Lexer, Stille-Luer) use tempered jaws ground to a controlled angle and tested to specific load cycles. Rongeurs (Kerrison, Cushing, Stille) bite cortical bone with a downcutting or up-biting action, removing chips for spinal or neurosurgical decompression. Bone-holding forceps (Lambotte, Lowman, Verbrugge) stabilize fracture fragments while implant systems engage. Osteotomes and chisels (Smith-Petersen, Hibbs, Cobb) require hardened tool-grade stainless or tungsten-carbide inserts to retain a cutting edge. Fizza manufactures the full bone-surgery catalogue from AISI 440 and 17-4 PH stainless under ISO 13485:2016.

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.

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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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