What certifications does the product have?

The product is FDA certified and meets Orthopedic Drill Power Tools standards.

Class II Orthopedic Bone Drill Surgical Power Tool for Trauma and Spinal Surgery

Name: Class II Orthopedic Bone Drill Surgical Power Tool for Trauma and Spinal Surgery
Brand: Shaanxi Ansen Medical Technology Development Co., Ltd.
SKU: 2260694135

Shaanxi, ChinaShaanxi Ansen Medical Technology Development Co., Ltd.

US$950.00-1,200.00

1 Piece

Sample price:US$1150.00/set.Request sample

Product profile

Customization

Available

Type

Bone Drill

Application

Orthopedic

Model NO.

AX-TSFZ-01

Material

Aluminum Alloy

Feature

Reusable

Certification

FDA, ISO13485

Group

Adult and Children

Property

Orthopedic Surgical Instruments

Motor

Brushless Motor

Working Voltage

10.8V

Type of Battery

Lithium Battery

Battery Capacity

2600mAh

Charging Time

≤1.5hours

Rated Speed(r.p.m)

1170

Torque(N.M)

Sterilization

135°C

Ambient Temperature Range

5°C ~ 35°C

Noise(Db)

≤75

Color

Black, Sliver, Tawny

MOQ

1 Set

Usage

Drilling Hole for Plate,Screw in Trauma Surgery

Weight

1.648kg

Transport Package

Standard Export Packaging

Specification

Orthopedic Drill Power Tools for Trauma Surgery

Trademark

Ansen

Origin

China

HS Code

9018909919

Production Capacity

600sets/ Month

Key features

Brushless Motor Technology: Delivers powerful performance, low energy consumption, and high reliability with reduced failure rate.

Precision Oscillating Mechanism: Scientifically optimized amplitude and frequency ensure precise cutting while minimizing tissue damage.

High-Capacity Lithium Battery: 2600mAh capacity provides extended runtime for long surgical procedures.

FDA Certified Safety: Meets FDA certification standards for safe and effective orthopedic surgical use.

Customizable OEM/ODM Services: Available for custom branding and product modifications to meet specific market needs.

Multiple Color Options: Available in Black, Silver, and Tawny to suit various clinical preferences.

Company profile

Shaanxi Ansen Medical Technology Development Co., Ltd.

Shaanxi, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service AvailableExport Year: 2013-01-01 CertifiedNearest Port: Shanghai PortAverage Response Time: ≤5.78h CertifiedTerms of Payment: T/T

AI-Powered supplier vetting

SummaryShaanxi Ansen Medical Technology Development Co., Ltd. is a China-based limited company established in 2003, manufacturing medical and orthopedic fiberglass products and related repair solutions. It reports 172 employees, five production lines, a 14,200 m² manufacturing area, 21 R&D engineers, and stated output for fiberglass casting tapes, fiberglass splints, and pipe repair bandages. The supplier has exported since 2013, holds self-operated import/export rights, and serves markets including South America, Southeast Asia, the Middle East, and Australia. Its lead time is stated as within 15 working days in both off-peak and peak seasons. No supplier-management-system certification is reported. Evidence supports established manufacturing and export capability, while after-sales service, customization, financial credibility, and customer-case depth remain insufficiently documented.

Supplier typeThe supplier is explicitly identified as a limited company and manufacturer of medical and orthopedic fiberglass products, with its own manufacturing plant, five production lines, and product portfolio. This supports classification as a manufacturer rather than only a trading intermediary.

CertificationsThe supplier-management-system certification field is explicitly reported as “NIL.” No other certification evidence is provided, so there is no documented certification holding in the supplied information.

R&D capabilityThe supplier states that its mission includes research and development, reports 21 R&D engineers, and describes a research laboratory established through cooperation with an American partner. These points provide explicit evidence of organized R&D activity and product-development capability.

Production capacityProduction capability is supported by five production lines, a 14,200 m² manufacturing plant, and stated annual quantities of 20 million fiberglass casting tapes, 10 million fiberglass splints, and 15 million pipe repair bandages. The supplier also states lead times within 15 working days in both off-peak and peak seasons, indicating substantial documented capacity.