Screwdriver, Surgical

Who Makes This Device Type in China?

One manufacturer in China holds an FDA registration for this device type, based in Guangdong. All of them are contract manufacturers, able to build to a buyer’s own specification.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer

What Is FDA Product Code LRZ?

Screwdriver, Surgical is FDA product code LRZ, Class 1, 21 CFR 878.4800.

How Does It Reach the US Market?

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 Do the Recalls Say?

The FDA has recorded 6 recalls under this product code since 2013. None was by a company in China. The root causes the FDA records most often are Component design/selection (5) and Nonconforming Material/Component (1).

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

Screwdriver, Surgical

BE POD Medio AR Pied Poignee Droite Mini AO

Catalogue number 0190 01 00, listed by Askorn Medical, France, under Screwdriver, Surgical. 1 manufacturer in China is registered for this product code.

Screwdriver, Surgical

Screwdriver Shank, Cannulated, Large AO Connector, WS 5, L=250mm

Catalogue number 54502-250, listed by I.T.S. Gmbh, Austria, under Screwdriver, Surgical. 1 manufacturer in China is registered for this product code.

Screwdriver, Surgical

T-Handle

T-Handle, Cannulated, Quick Fastener

Screwdriver, Surgical

Volt™ Wrist Treatment System

Cannulated Screwdriver Shaft T8/Quick Coupling/105mm

Screwdriver, Surgical

Screwdriver

Alif Screwdriver

Screwdriver, Surgical

Humelock II Cemented Shoulder System

HUMELOCK HEX 6/3.5mmSCREWDRIVER

Screwdriver, Surgical

Ziptek Knotless Tissue Repair and Attachment Devices

Ziptek large stainless steel driver/handle assembly reusable medical grade stainless steel ofr use with large 5.0mm screws and biocomposite plugs and as ZipE capture/button pusher

Screwdriver, Surgical

Hex Screw Driver

Catalogue number 7330-93, listed by Koros U.S.A., Inc., under Screwdriver, Surgical. 1 manufacturer in China is registered for this product code.

Screwdriver, Surgical

Screwdriver, Surgical

Catalogue number NSI-0106, listed by NSI-US, Inc., United States, under Screwdriver, Surgical. 1 manufacturer in China is registered for this product code.

Screwdriver, Surgical

Screwdriver

Screw Driver, Handle 25mm, WS 2.5, L=170mm, Can. 1.7mm

Screwdriver, Surgical

Hintermann Series

Cortical Screwdriver Instrument

Screwdriver, Surgical

Bespa Charcot System

Driver Handle, AO

Screwdriver, Surgical

AoN Implants

Ratcheting Screwdriver detachable complete. Cross Head

Screwdriver, Surgical

Dynex

DYNEX TRIAD Adjustment Tool

Screwdriver, Surgical

Screwdriver, Cannulated, SW 5mm, L=220mm

Catalogue number 56502-220, listed by I.T.S. Gmbh, Austria, under Screwdriver, Surgical. 1 manufacturer in China is registered for this product code.

Screwdriver, Surgical

Screwdriver Shank

Screwdriver Shank, PRS, Solid, WS 3.5, L=230mm, AO Connector

Screwdriver, Surgical

ClearPoint

SF M6 Bolt Driver

Screwdriver, Surgical

Screw Driver

Screw Driver, WS 3.5, Conic, Self Holding

Screwdriver, Surgical

Leos Cannulated Screw System

T30 Driver Large AO

Screwdriver, Surgical

HDC

Contra angle driver TAD key

Screwdriver, Surgical

Hexagon-Shank

Hexagon-Shank, WS 2.5, L=100mm, Cannulated, AO Connector

Screwdriver, Surgical

Lsss

AO Screwdriver Spinner (This Part Fits Onto THE Bottom END OF "AO Canulated Silicone Screwdriver Handle With Quick Coupling, RM06006 - Primary DI NO# (0506433600876)". This Instrument Part…

Screwdriver, Surgical

Snap-Off Screw System Instruments

Snap Off Driver

Screwdriver, Surgical

Large Hexagonal Screwdriver

Large Hexagonal Screwdriver, 3.5mm, Quick Coupling End

Screwdriver, Surgical

A.l.p.s. Mvx™

T15 Retention Driver Long R

Screwdriver, Surgical

Faico CMF System

Screwdriver detachable complete. Self Fitting. Hexagon Head

Screwdriver, Surgical

P-K Titanium Motility Peg System

Titanium Threaded Sleeve Driver (Wrench) used with IOI's Titanium Threaded Sleeve/Flat Peg (I00045) and Titanium Large Threaded Sleeve/Flat Peg (I00100). Manual, single-use, nonsterile…

Screwdriver, Surgical

Dental Instrument

26 catalogue numbers from KMATD18L, listed by Cowellmedi Co., Ltd., South Korea, under Screwdriver, Surgical. 1 manufacturer in China is registered for this product code.

Screwdriver, Surgical

Bioplate®

Short Screwdriver Blade - Cross Drive - Handle (B)

Screwdriver, Surgical

Torque Shank

Torque-Shank, T9x100, Cannulated, AO Connector

Screwdriver, Surgical

Titanex

TITANEX ARTEMIS Cannulated T10 Retaining Driver

Screwdriver, Surgical

Orthomed

Stardrive Screwdriver Shaft T15 QC Self-Retain 100

Screwdriver, Surgical

Screw Driver Torque

Screw Driver Torque,

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer