Screwdriver, Skullplate

Which Manufacturers in China Make This?

2 manufacturers in China hold an FDA registration for this device type, based in Shaanxi and Shanghai.

Kontour (Xi'an) Medical Technology Co., Ltd. Shaanxi, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer

How Is GXL Classified?

Screwdriver, Skullplate is FDA product code GXL, Class 1, 21 CFR 882.4900.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2006. None was by a company in China. The root cause the FDA records most often is Labeling design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Screwdriver, Skullplate

Neuro & Craniofacial Fixation System

2 catalogue numbers from LS-424, listed by Inno-Health Technology Co., Ltd., Taiwan, under Screwdriver, Skullplate. 2 manufacturers in China are registered for this product code.

Screwdriver, Skullplate

Screwdriver

Catalogue number 353-01, listed by Neurovention, LLC, United States, under Screwdriver, Skullplate. 2 manufacturers in China are registered for this product code.

Screwdriver, Skullplate

Skull Reference Screwdriver Blade

Catalogue number 52175, listed by Brainlab SE, Germany, under Screwdriver, Skullplate. 2 manufacturers in China are registered for this product code.

Screwdriver, Skullplate

Neuro Plating System

Driver Shaft for Power Driver

Screwdriver, Skullplate

Surgical Instrument

4 catalogue numbers from 24-QD-001, listed by Jeil Medical Corporation, South Korea, under Screwdriver, Skullplate. 2 manufacturers in China are registered for this product code.

Screwdriver, Skullplate

Disposable Screwdriver Blade

2 catalogue numbers from BPLD60×φ2.8, listed by Kontour (Xi'an) Medical Technology Co., Ltd., China, under Screwdriver, Skullplate. 2 manufacturers in China are registered for this product code.

Screwdriver, Skullplate

Seeg Short Bolt Driver

Catalogue number SEEGINST02, listed by Biomet Microfixation, United States, under Screwdriver, Skullplate. 2 manufacturers in China are registered for this product code.

Screwdriver, Skullplate

Skull Reference Screwdriver Handle

Catalogue number 52174, listed by Brainlab SE, Germany, under Screwdriver, Skullplate. 2 manufacturers in China are registered for this product code.

Screwdriver, Skullplate

Seeg Long Bolt Driver

Catalogue number SEEGINST01, listed by Biomet Microfixation, United States, under Screwdriver, Skullplate. 2 manufacturers in China are registered for this product code.

Screwdriver, Skullplate

OsteoMed

1.6MM Driver Stem W/Post, AO Shnk, Short

Screwdriver, Skullplate

1.0MM/1.3MM Scrwdriver Blade FOR Raised HD Scrw/HEX CO/86MM

Screwdriver, Skullplate

ProDriver Battery Pack, Single

Catalogue number PDBP-001-2, listed by Pro-Dex Inc, United States, under Screwdriver, Skullplate. 2 manufacturers in China are registered for this product code.

Screwdriver, Skullplate

Hex Screwdriver Ball-End (2.5 MM)

Catalogue number 55758-30, listed by Brainlab SE, Germany, under Screwdriver, Skullplate. 2 manufacturers in China are registered for this product code.

Screwdriver, Skullplate

Which Manufacturers in China Make This?

How Is GXL Classified?

What Does It Take to Sell It in the United States?

What Has Gone Wrong With It?

Where China Actually Supplies