What is the classification of this instrument?

It is classified as a Class III implantation equipment, indicating high-risk medical devices requiring strict control.

3.5mm Acromial Clavicle LCP Locking Plate

Name: 3.5mm Acromial Clavicle LCP Locking Plate
Brand: CHANGZHOU XIETONG INDUSTRIES CO., LTD.
SKU: 2002787485

Jiangsu, ChinaCHANGZHOU XIETONG INDUSTRIES CO., LTD.

US$60.00-70.00

10 Pieces

Sample price:US$105.00/piece.Request sample

Product profile

Customization

Available

Customized

Non-Customized

Certification

ISO, CE

Condition

New

Usage

Fracture Fixation

Using Site

Small Fragment

Type

External Fixator

Transport Package

Carton

Specification

6 +4hole-6+8 hole

Origin

China

HS Code

9021909090

Production Capacity

10000/Mon

Key features

ISO & CE Certified Quality: Certified under ISO 13485 and CE standards with a complete quality management system.

High-Precision Manufacturing: Produced using advanced 5-axis and 9-axis CNC machines from Germany, USA, and Japan.

OEM Service Accepted: Supports OEM production according to customer requirements and branding needs.

Titanium Material Construction: Made from high-quality Titanium suitable for small fragment fracture fixation.

Class III Medical Device: Classified as a Class III implantation equipment for strict safety compliance.

Fast Lead Time: Average lead time within 15 workdays for both peak and off-season periods.

Company profile

CHANGZHOU XIETONG INDUSTRIES CO., LTD.

Jiangsu, China

Business Type: Manufacturer/Factory, OtherExport Year: 2013-02-06 CertifiedNearest Port: Shanghai PortAverage Response Time: ≤8.14h CertifiedTerms of Payment: LC, T/T, D/P, etc. CertifiedInternational Commercial Terms(Incoterms): FOB, CIF, CFR

AI-Powered supplier vetting

SummaryCHANGZHOU XIETONG INDUSTRIES CO., LTD. is presented as an orthopedic implant and instrument supplier with OEM production. The evidence shows more than 10 production lines, 31–40 quality-control staff, broad export-market coverage, 90% export sales, and direct import-export rights. Its product records include femur and humerus nailing instruments, screw-holding devices, and tibia nail components, with transactions linked to buyers in India. The supplier states that it accepts LC and T/T payments and quotations under FOB, CIF, and EXW terms. However, the provided information does not establish certifications, after-sales service arrangements, financial credibility, or detailed customer performance outcomes. Customization capability is supported by the stated OEM production and OEM instrument designs, although the description is brief.

Supplier typeThe supplier is identified through multiple records as an orthopedic-instrument provider, offering femur and humerus nailing instruments, screw-holding devices, and tibia nail components. Its company description also states that it produces orthopedic implants and instruments, including OEM products and designs, indicating a manufacturer/OEM supplier profile rather than only a trading role.

R&D capabilityThe supplier states that it offers OEM production and OEM instrument designs, which supports some product-development and design adaptation capability. However, there is no evidence of proprietary research, patents, new product development, or dedicated R&D resources, so broader innovation strength remains unverified.

Production capacityThe supplier reports more than 10 production lines and 31–40 quality-control staff, with a one-month off-peak lead time and a two-to-three-month peak-season fulfillment period. It also reports export coverage across multiple global regions and 90% of sales from exports, supporting substantial production and fulfillment capacity.

Customization capabilityThe company description explicitly states that it provides OEM production and OEM-design instruments, indicating capability to support customer-specific product or design requirements. The available information does not define the scope, engineering process, or limits of customization.

Client casesThe records identify AUXEIN MEDICAL PRIVATE LIMITED as an associated buyer across several orthopedic-instrument transactions and BONETECH MEDISYS PRIVATE LIMITED in another record. These entries demonstrate named buyer relationships and product transactions, but they do not provide customer testimonials, order scale, repeat-performance data, or outcome metrics.