Countersink

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shanghai and Guangdong: 5 hold an FDA registration. 1 is a contract manufacturer.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
Changzhou Centrau Medical Instrument Co., Ltd. Jiangsu, contract manufacturer
Changzhou Xietong Industries Co., Ltd. Jiangsu
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer

How Is HWW Classified?

Countersink is FDA product code HWW, Class 1, 21 CFR 888.4540.

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 Has Gone Wrong With It?

The FDA has recorded 17 recalls under this product code since 2012. None was by a company in China. The root cause the FDA records most often is Component design/selection (1).

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

Darco

Drill Bit Countersink FSK System

Orion Headed Screw System Instruments

2.0 Headed Screw Countersink

Healix

2.0 Headless Countersink. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for,…

Tiger

3.0/4.0mm Cann. Screw Countersink

Medline

MSN20007 @countersink, 7.0 Headed, Cante

Cannulated Screw System

SQC Countersink

Made-To-Order

Evolve Triad Countersink

Inion FreedomScrew Instruments

Countersink for 3.5 - 4.5 mm screws, cannulated

Medartis

2 catalogue numbers from A-3938, listed by Provision, under Countersink. 5 manufacturers in China are registered for this product code.

Countersink

Countersink Ø6.2, cannulated, I-Ø2.6, L 120, Hudson coupling

Gsource

Countersink 2 3/4" 2.7/3.5/4.0mm SQC 2.0mm tip

Tools – HCS

Countersink 3.5mm, HCS

Countersink

Countersink with AO-Connector for screws DIA 3.0/ 4.3 mm cannulated for K-Wire DIA 1.4 mm non-sterile

Active Compression

5.5mm Cannulated Countersink, Active Compression

Dart-Fire

9 catalogue numbers from DSDS1040, listed by Wright Medical Technology, Inc., United States, under Countersink. 5 manufacturers in China are registered for this product code.

OrthoSolutions ‘System26’ Bone Screws

Countersink FOR 6.5MM Headless Screw Cannulated Jacobs QC

Wright

Catalogue number DSDS0049, listed by Wright Medical Technology, Inc., United States, under Countersink. 5 manufacturers in China are registered for this product code.

Countersink

Countersink with handle

Ortho Solutions Succession AFN System

Succession Countersink

NexFix

Washer Counterbore

Ambler Surgical

Quick coupling countersink, 2 3/4'', small, 2.0mm tip, round handle

MaxLock

MTP PocketLock™ COUNTERSINK

Drill Bit

5 catalogue numbers from 111-094, listed by Jeil Medical Corporation, South Korea, under Countersink. 5 manufacturers in China are registered for this product code.

Stryker

4 catalogue numbers from 702811, listed by Provision, under Countersink. 5 manufacturers in China are registered for this product code.

Countersink

Countersink FOR 3.5 Cortex AND 4.0 Cancellous Screws/Yellow

Ultra Compression Screw System

Headed Countersink, S 7.5mm

Cannulated Screw Countersink

Catalogue number 329706, listed by Biomet Orthopedics, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Vilex Tool

Countersink, One-Piece Blunt 2.0

Headed Screw System Instruments

6.0 / 6.5 Screw Countersink

Countersink

Catalogue number 58870002, listed by Wright Medical Technology, Inc., United States, under Countersink. 5 manufacturers in China are registered for this product code.

Leos Cannulated Screw System

Countersink 2.5/3.0 Cann HLESS Screws

Noprofile Countersink

Catalogue number 904308, listed by Biomet Orthopedics, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Evolve Triad

3 catalogue numbers from 49510121, listed by Wright Medical Technology, Inc., United States, under Countersink. 5 manufacturers in China are registered for this product code.

Biodrive Cannulated Screw SYS

3 catalogue numbers from 14-450265, listed by Biomet Orthopedics, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Titanex

TITANEX ULTRA COUNTER SINK, dia 2.0MM SCREW, HEADED

Self-Centering Coutersink, Small

Catalogue number FCS 901, listed by Flower Orthopedics Corporation, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Percufix

Countersink, Cannulated

Magna-FX®

Catalogue number 1142-17, listed by Zimmer, Inc., United States, under Countersink. 5 manufacturers in China are registered for this product code.

Countersink

Countersink FOR 3.5MM Cortex AND 4.0MM Cancellous Bone Screws

Inion® Universal Instruments

Countersink 4.5, cannulated (AO-bayonet)

Gridlock Washer Countersink

Catalogue number 310-40-002, listed by Trilliant Surgical LLC, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Alphalok Plating System

MET FX 2.0/2.5mm Countersink

Arthrex

2 catalogue numbers from AR-8737-24, listed by Provision, under Countersink. 5 manufacturers in China are registered for this product code.

Charlotte

Lisfranc Countersink

Fuse Ultra Foot Plating System

Drill/Countersink combo QC 4.0 Cannulated Screw

Cannulated Countersink, 3.0/3.5/4.0/4.5

2 catalogue numbers from CCS 135, listed by Flower Orthopedics Corporation, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Synthes

4 catalogue numbers from 310.890, listed by Provision, under Countersink. 5 manufacturers in China are registered for this product code.

Cardinal Health

Countersink 3.5mm Cortex/4.0mm Cancellous Bone Screws

GEO Bone Screw System

Countersink Tip 7mm/8mm Bone Screw Hudson

Paragon 28

3 catalogue numbers from P20-910-4000, listed by Provision, under Countersink. 5 manufacturers in China are registered for this product code.

Mini Countersink

Mini Countersink, 1.1mm Tip, Quick Coupling End

A.l.p.s. Mvx™

2.7/3.5/4.0MM Countersink R

Summa Orthopaedics System Surgical Instrument

5 catalogue numbers from SO-111-135, listed by Jeil Medical Corporation, South Korea, under Countersink. 5 manufacturers in China are registered for this product code.

In2Bones

Catalogue number P06 N0711, listed by Provision, under Countersink. 5 manufacturers in China are registered for this product code.

Cortical Counter Sink

Cortical Counter Sink, for HCS D=3.0mm

Tools-SHD

Countersink 2.3mm, SHD

Flow-Screw™

FS Medium Countersink

Tools – LHS

Countersink 4.5mm, LHS

Phantom® Fibula Nail System

Screw Countersink, AO Quick Connect

WasherCap™ Countersink 8 Mm

WasherCap™ Countersink 8 mm: 1 catalogue number listed by Abanza Tecnomed SL., under Countersink. 5 manufacturers in China are registered for this product code.

Evolve

EPS Countersink

WasherCap™ Countersink 11 Mm

WasherCap™ Countersink 11 mm: 1 catalogue number listed by Abanza Tecnomed SL., under Countersink. 5 manufacturers in China are registered for this product code.

Newclip Instruments

2 catalogue numbers from ANC1607, listed by Newclip Technics SAS, France, under Countersink. 5 manufacturers in China are registered for this product code.

WasherCap™ Countersink 9 Mm

WasherCap™ Countersink 9 mm: 1 catalogue number listed by Abanza Tecnomed SL., under Countersink. 5 manufacturers in China are registered for this product code.

Smith and Nephew

2 catalogue numbers from 71170075, listed by Provision, under Countersink. 5 manufacturers in China are registered for this product code.

Tools – HPS

Countersink 1.2mm/1.5mm, HPS

Prometheus System Surgical Instrument

3 catalogue numbers from PRO-90119, listed by Jeil Medical Corporation, South Korea, under Countersink. 5 manufacturers in China are registered for this product code.

3.5mm Countersink

Catalogue number 110500, listed by OsteoCentric Technologies,Inc, United States, under Countersink. 5 manufacturers in China are registered for this product code.

TCP

2 catalogue numbers from 08-711, listed by Wright Medical Technology, Inc., United States, under Countersink. 5 manufacturers in China are registered for this product code.

Volition Plating System

Countersink FOR 3.5MM Headless Screw Cannulated AO QC

Ortholoc 3DI

Catalogue number 52030607, listed by Wright Medical Technology, Inc., United States, under Countersink. 5 manufacturers in China are registered for this product code.

FO Micro Screw System

FO Countersink (Cannulated)

WasherCap™ Countersink 7 Mm

WasherCap™ Countersink 7 mm: 1 catalogue number listed by Abanza Tecnomed SL., under Countersink. 5 manufacturers in China are registered for this product code.

No Profile Countersink

Catalogue number 904308, listed by Biomet Orthopedics, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Tools – AFS

Countersink 4.0mm, AFS

AO Countersink, Medium, Cannulated

Catalogue number FCS 912, listed by Flower Orthopedics Corporation, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Flex-Thread

Double Drill Guide- 1.9/2.7mm

Quick-Connect

3 catalogue numbers from 4809-27, listed by Zimmer, Inc., United States, under Countersink. 5 manufacturers in China are registered for this product code.

Vilex Jones Fracture Tool

Countersink, Jones Fracture 5.5mm

Arsenal Ankle

Malleolus Implant Countersink

Phantom Hindfoot TTC/TC Nail System

Phantom Curved Nail, Reamer Entry Countersink, 7mm

Inlet System Surgical Instrument

3 catalogue numbers from IN111-135, listed by Jeil Medical Corporation, South Korea, under Countersink. 5 manufacturers in China are registered for this product code.

Cannulated Countersink 5.5/6.5/7.3

Catalogue number CCS 080, listed by Flower Orthopedics Corporation, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Flower Orthopedics

Catalogue number CDG 200, listed by Flower Orthopedics Corporation, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Wright

Catalogue number MSD-070-40, listed by Provision, under Countersink. 5 manufacturers in China are registered for this product code.

Cortical Sink

Catalogue number 63403-150, listed by I.T.S. Gmbh, Austria, under Countersink. 5 manufacturers in China are registered for this product code.

Countersink

PDS Countersink

AO Countersink, Large, Cannulated

Catalogue number FCS 913, listed by Flower Orthopedics Corporation, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Decima Spine Instrument Kit

Catalogue number 6093, listed by Decima Spine, Inc., under Countersink. 5 manufacturers in China are registered for this product code.

Artemis Fuze

ARTEMIS FUZE Countersink, 3.0mm

Countersink

2 catalogue numbers from 14-440049, listed by Biomet Orthopedics, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Gridlock Ankle Screw Countersink

Catalogue number 320-35-002, listed by Trilliant Surgical LLC, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Extremity Medical

Catalogue number 127-00004, listed by Provision, under Countersink. 5 manufacturers in China are registered for this product code.

Kmedic

Countersink 4 3/4" 3.2 Millimeter Malleolar

Countersink

A T-handled instrument used to manually enlarge the diameter of the proximal portion of bone canal in preparation for insertion of the CurvaFix Implant.

Ortholoc SPS

Countersink Tool

Verum System Surgical Instrument

4 catalogue numbers from VC0040, listed by Jeil Medical Corporation, South Korea, under Countersink. 5 manufacturers in China are registered for this product code.

COGNiTiON™ Staple System

COGNiTiON COUNTERSINK

Level ONE

Countersink, LAG, FOR USE W/Mini Driver OR Jacobs Chuck

Level ONE Transbuccal

Countersink, LAG, FOR 50-317-00-07

Surgical Instrument

Catalogue number 111-223, listed by Jeil Medical Corporation, South Korea, under Countersink. 5 manufacturers in China are registered for this product code.

Trauma Screw System Instruments

2.5 / 3.0 Screw Countersink

Diamond Orthopedic, LLC

Countersink - cannulated, for 2.4mm cannulated screws

Ortholoc™ 2 Jones Fracture System

3 catalogue numbers from 56034500, listed by Wright Medical Technology, Inc., United States, under Countersink. 5 manufacturers in China are registered for this product code.

Self-Centering Countersink, Medium

Catalogue number FCS 902, listed by Flower Orthopedics Corporation, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Resorbable Bone Screw

2 catalogue numbers from 950037, listed by Biomet Orthopedics, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Small Cannulated Countersink AO 125mm

Catalogue number 320-0010, listed by OsteoCentric Technologies,Inc, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Solid Countersink, 3.0/3.5/4.0/4.5

Catalogue number CCS 159, listed by Flower Orthopedics Corporation, United States, under Countersink. 5 manufacturers in China are registered for this product code.

2.4mm/3.0mm Gridlock Screw Countersink

Catalogue number 310-30-002, listed by Trilliant Surgical LLC, United States, under Countersink. 5 manufacturers in China are registered for this product code.

Redemption

6.5mm Counter sink

Tools – DHF

Countersink, Medial Nail Plate

Autofix

2 catalogue numbers from 907-0013, listed by Stryker GmbH, Switzerland, under Countersink. 5 manufacturers in China are registered for this product code.

Arsenal Foot

2.7mm/3.5mm/4.0mm Arsenal Screw Countersink

GEO

Catalogue number 23000036, listed by Provision, under Countersink. 5 manufacturers in China are registered for this product code.

TriMed

Catalogue number HSINK3.5, listed by Provision, under Countersink. 5 manufacturers in China are registered for this product code.

Cannulated Countersink, 2.0/2.4

Catalogue number CCS 035, listed by Flower Orthopedics Corporation, United States, under Countersink. 5 manufacturers in China are registered for this product code.

WasherCap™ Countersink 10mm

WasherCap™ Countersink 10mm: 1 catalogue number listed by Abanza Tecnomed SL., under Countersink. 5 manufacturers in China are registered for this product code.

Gridlock Ankle Washer Countersink

Catalogue number 320-40-002, listed by Trilliant Surgical LLC, United States, under Countersink. 5 manufacturers in China are registered for this product code.

2.7mm Countersink

PDS Countersink

Mica

Catalogue number 57S01040, listed by Wright Medical Technology, Inc., United States, under Countersink. 5 manufacturers in China are registered for this product code.

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