icotec Systems, Torque-Limiting Adapter, 3.5 Nm

Basic Information

• Brand Name: icotec Systems, Torque-Limiting Adapter, 3.5 Nm
• Primary DI: 07640172552872
• Version / Model: 60-035
• Catalog Number: 60-035
• Company Name: icotec AG
• Labeler DUNS: 480789465
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-05
• Public Version: 3
• Public Version Date: 2026-03-25
• Public Version Status: Update
• Public Device Record Key: 3695114c-4e6a-4342-8b72-1081d984612a
• Distribution End Date: 2026-03-24

Device Description

icotec Systems, Torque-Limiting Adapter, 3.5 Nm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	888.3070	2
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	888.3027	2
NKG	Posterior Cervical Screw System	Orthopedic	888.3075	2
OLO	Orthopedic Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47858	Surgical instrument torque limiter	A small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640172552872	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]