Twister, Wire

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are based in Shanghai and Shandong: 3 hold an FDA registration. 1 is a contract manufacturer.

MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Xinhua Healthcare Industry Co., Limited Shandong, contract manufacturer

What Is FDA Product Code HXS?

Twister, Wire is FDA product code HXS, Class 1, 21 CFR 888.4540.

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 Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2010. None was by a company in China. The root cause the FDA records most often is Employee error (1).

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

Sternal Wire Twister Needle Holder

Sternal Wire Twister Needle Holder Tungsten Carbide Serrated Broad TIP

Rod Holder Clamp

Rod Holder Clamp for 4.5-6.5mm Rod, 7-1/4" Total Length

Wire Twister Needle Holder

Wire Twister With Hole Needle Holder Style Gold Coated Handle

Twister

Wire, Extra Delicate, TC

Symmetry Surgical

Symmetry® Pliers; Wire Twister and Tightener; 6 1/4 in

Loute Wire Twister

Loute Wire Twister Stainless Steel

Double Wire Twister

Catalogue number 232.001.00, listed by Jace Medical, LLC, United States, under Twister, Wire. 3 manufacturers in China are registered for this product code.

BIO-MET Wire Twister

BIO-MET Wire Twister Aluminum Handle

Sierra

Catalogue number 95-0124, listed by Seaspine Orthopedics Corporation, United States, under Twister, Wire. 3 manufacturers in China are registered for this product code.

Valkyrie Wire Twister

Catalogue number 03-WT-01, listed by Sontec Instruments, Inc., United States, under Twister, Wire. 3 manufacturers in China are registered for this product code.

Inka

McGEE black Wire Crimping Forceps ø 1.1mm 5.5mm jaw shaft length 80mm

Axel Wire Twister/Cutter

Axel Wire Twister/Cutter With Hole Needle Holder Style Heavy Jaw

JET Wire Twister Needle Holder

JET Wire Twister Needle Holder Corkscrew Design Tungsten Carbide Heavy Broad TIP

Axel Wire Twister

Axel Wire Twister With Hole Round TIP Extra Extra Large Size Heavy Duty

Cerclage Wire Twister

Cerclage Wire Twister Double Torpedo Type Phenolic Handle Stainless Steel

JET Automatic Wire Twister

JET Automatic Wire Twister With Cutter

Twister, Wire

Catalogue number 1292-97, listed by Zimmer, Inc., United States, under Twister, Wire. 3 manufacturers in China are registered for this product code.

Neon3

Trocar tipped drill wire, Ø 1.5 mm, length 410 mm

Coral

Guide Wire Stainless Steel Non-Threaded 500m

Integra® Miltex®

Integra® Miltex® Wire Pulling Forceps, 6-1/2", 1mm Maximum Capacity

Paramount

Guide wire; Trocar (03-1112-01)

JET Wire Twister

JET Wire Twister Miniature Tungsten Carbide TIP

Rubio Wire Twister/Needle Holder

Rubio Wire Twister/Needle Holder Tungsten Carbide Tips Heavy

Symmetry Corwin

Symmetry® Pliers; Corwin Wire Twister; Delicate; 6 1/4 in

A&E Medical / Wire Twister

Wire Twister, 1 per pouch

BIO-MET Type Wire Twister

Catalogue number 1103-171, listed by Sontec Instruments, Inc., United States, under Twister, Wire. 3 manufacturers in China are registered for this product code.

Wire Bender

Catalogue number 1103-156, listed by Sontec Instruments, Inc., United States, under Twister, Wire. 3 manufacturers in China are registered for this product code.

Arthrex®

Wire Tensioner Nose, Long

JET Automatic Wire Twister/Cutter

Catalogue number 1103-158E, listed by Sontec Instruments, Inc., United States, under Twister, Wire. 3 manufacturers in China are registered for this product code.

Symmetry Loute

Symmetry® Tightener; Loute Wire; 8 1/2 in

Ambler Surgical

Corwin wire twister, 6 1/8'', heavy, 10.0mm serrated TC jaws, round tip, twisted center ring, gold ring handle

Avalign

Wire Twister,

Adler Instrument Company

TC Rubio Sternal NH 5-1/4

Anti Buckle Wire Twister

Anti Buckle Wire Twister With Guard Tungsten Carbide Tips

Symmetry Ultra®

Symmetry® Pliers; Wire Twister; Delicate; Tungsten Carbide; 6 1/8 in

RZ Medizintechnik GmbH

CORWIN TC Wire Twister 15.0mm, 6", with tightener

Novo Surgical

wire twister & tightener, 6 1/4" (15.9 cm)

NewPort

520mm Nitinol Guidewire, Double Blunt and Threaded

Malibu

Sublaminar Wire, Sterilization Tube

Twister, Wire

K-Wire Adaptor FOR 2.8MM K-Wires

Pilling

5 catalogue numbers from IPN017940, listed by Teleflex Medical LLC, United States, under Twister, Wire. 3 manufacturers in China are registered for this product code.

Kmedic

Wire Twisting Forceps, 7 1/4 ", Tungsten Carbide

NEW Orleans Wire Twister

NEW Orleans Wire Twister Needle Holder Rounded Tungsten Carbide Serrated TIP

Integra® Jarit®

Integra® Jarit® Berry Sternal Needle Holder And Wire Twister, 7-1/4", Carb-Bite, Heavy, 5mm Wide

Orthomed

Pliers, Narrow Nose Wire Pull. 7 1/2

Ucentum

Guidewire, Ø 1.5 mm, length 500 mm

Boss Instruments

Kirschner Bow, extra long 5' min spread, 9 1/2 max 11" OL

Durogrip

DUROGRIP Wire Twister, straight, 6 1/8", (155 mm), with 0.5 mm pitch of serration, with ratchet, non-sterile, reusable

Sklar®

Censitrac Ready TC Baumgartner Wire Twister 8"

Forceps

Twisting, Wire, Corwin, Hegar, TC

Wire Twister

Wire Twister Tungsten Carbide Serrated Blunt Jaw With Serrated Top

Zoll-Dental

#23 Wire Twister Carbide 15cm

Twister, Wire

12 catalogue numbers from 51-6700, listed by Biomet Microfixation, United States, under Twister, Wire. 3 manufacturers in China are registered for this product code.

Novo Surgical Inc.

wire twister, cross-serrated nose, blunt jaws, tungsten carbide inserts, 8 1/4" (21.0 cm)

Medicon

Obwegeser flat nose pliers 13cm w groove

Aesculap

RUBIO Needleholder, 5", (127 mm), non-sterile, reusable

Gsource

Combination Wire Cutter DA and Twister 9", serr jaw 8mm, TC, max cap 1.6mm [.062”]

Millennium

Tungsten Carbide Berry Wire Twister . round tip serrated

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