Instrument, Cutting, Orthopedic

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Shanghai, Zhejiang and Shandong, and 3 other provinces: 11 hold an FDA registration. 3 are contract manufacturers.

Bothwin (Beijing) Medical Technology Co., Ltd. Beijing
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
Hangzhou Endo Medical Instrument Co., Ltd. Zhejiang, contract manufacturer
Hangzhou Kangji Medical Instrument Co., Ltd. Zhejiang, contract manufacturer
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
Shanghai Lange Medtech Co., Ltd. Shanghai
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Xinhua Healthcare Industry Co., Limited Shandong, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code HTZ?

Instrument, Cutting, Orthopedic is FDA product code HTZ, Class 1, 21 CFR 878.4800.

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 27 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Device Design (2), Nonconforming Material/Component (1) and Process control (1).

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

Instrument, Cutting, Orthopedic

Cushing Rongeur, Oval 2x10mm, 16cm WL

Catalogue number 02-202-07, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Gentle Threads Threaded Dilator

Catalogue number 905659, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Atec Instruments

Kerrison, 4MM

Instrument, Cutting, Orthopedic

Evolve Triad

Plate Cutter

Instrument, Cutting, Orthopedic

VariTrax Instrument Kit

Catalogue number CFIK-INST, listed by Circumfix Solutions, Inc, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Decker Rongeur, Round 2mm, 14cm WL

Catalogue number 02-082-21, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Sigma Pathway

Sigma Pathway Femoral Chamfer Block Size 6

Instrument, Cutting, Orthopedic

Instrument, Cutting, Orthopedic

2 catalogue numbers from 5100-00-052, listed by Zimmer, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Oxford Unicompartmental Knee Phase 3POSTERIOR Osteophyte Chisel

Catalogue number 32-422344, listed by Biomet UK Ltd., United Kingdom, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Kerrison Rongeur, 2mm, 40 Degrees Down, 15.5cm WL

Catalogue number 07-181-23MA, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Sternal Cable System

Cable Cutter

Instrument, Cutting, Orthopedic

Timx

Timx LOW Back System Cannulated Screw Cutter M6

Instrument, Cutting, Orthopedic

LapiLock

LapiLock Bone Cut Guide Single Slot

Instrument, Cutting, Orthopedic

Stille Giertz Rib Shears

Catalogue number 430-356, listed by Sontec Instruments, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Gentle Threads Screwdriver

Catalogue number 905650, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Gentle Threads Tunnel Notcher

Catalogue number 905652, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Symmetry Cleveland

Symmetry® Forceps, Cleveland Bone Cutting, Angled, 5 3/4 in

Instrument, Cutting, Orthopedic

Hook Scissors

Hook Scissors With Overload Cone Angled Right

Instrument, Cutting, Orthopedic

Depuy Spine

Depuy Spine Cable System BY Songer Cable Cutter

Instrument, Cutting, Orthopedic

Van Sickle

Ruskin Bone Cutting Forceps 5-1/2" (140 mm) double action, straight

Instrument, Cutting, Orthopedic

9-10MM Modular BIO-Core Dilator

Catalogue number 905046, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

ReCap®

Catalogue number 31-600386, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Tendon Stripper

Catalogue number 350-790, listed by Sontec Instruments, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Gentle Threads Tunnel Dilator

Catalogue number 905651, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

First Choice Druj System

UH Disposable Pack FOR Stryker

Instrument, Cutting, Orthopedic

Wire Cutter

Catalogue number 100.11.115, listed by Zimmer, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Love-Gruenwald Rongeur, Oval 3x10mm, 16cm WL

Catalogue number 02-202-08, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

IQ

IQ Tibia/Distal Femur Cutting Guide

Instrument, Cutting, Orthopedic

LCS Complete

LCS Complete Pathway A/P Block SM+

Instrument, Cutting, Orthopedic

Rinsing Cannula

Rinsing Cannula With Stop Cock

Instrument, Cutting, Orthopedic

Symmetry Surgical

Symmetry® Cutter, Symmetry Dowel, 16 mm

Instrument, Cutting, Orthopedic

Weil-Blakesley Rongeur, Oval 3×2.9mm, 30 Degrees Up, 12cm WL

Catalogue number 07-181-28MA, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Sternal Cable System

Cable Cutter

Instrument, Cutting, Orthopedic

HammerTube System

Bone Planer, 8mm (Patent Pending)

Instrument, Cutting, Orthopedic

Symphony

SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5mm AND 4.0mm RODS

Instrument, Cutting, Orthopedic

Recap/Magnum HIP Instrumentation

Catalogue number 31-600386, listed by Biomet UK Ltd., United Kingdom, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Xspan Laminoplasty Fixation System

Plate Cutter, 9INCH

Instrument, Cutting, Orthopedic

Medtronic Reusable Instruments

Instrument 905-830 Mesh Trimmer

Instrument, Cutting, Orthopedic

Symmetry Dowel

Symmetry® Cutter, Symmetry Dowel, 14.0 mm Diameter

Instrument, Cutting, Orthopedic

Trumatch

TruMatch PERSONALIZED SOLUTIONS X-RAY CUT GUIDE KIT FOR USE WITH: RIGHT

Instrument, Cutting, Orthopedic

7-8MM Modular BIO-Core Dilator

Catalogue number 905045, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Inbone

Pin Cutter

Instrument, Cutting, Orthopedic

Decker Rongeur, Round 2mm, 45 Degrees Up, 10cm WL

Catalogue number 02-082-46, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Decker Rongeur, Round 2mm, 10cm WL

Catalogue number 02-082-47, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Arthroscopic Punch Hook Scissors

Arthroscopic Punch Hook Scissors Straight JAW

Instrument, Cutting, Orthopedic

Aesculap

CRANIOPLATE Plate Cutting Forceps, 4 3/4", (120 mm), non-sterile, reusable

Instrument, Cutting, Orthopedic

MaxLock

Hercules Cutter

Instrument, Cutting, Orthopedic

Summit

Summit Fixation System ROD Cutter

Instrument, Cutting, Orthopedic

Bone Cutter

Councilman Bone Cutter

Instrument, Cutting, Orthopedic

P.l.u.s.®

Catalogue number U1-A241, listed by Spinevision SAS, France, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Expedium

Expedium Spine System Table TOP ROD Cutter

Instrument, Cutting, Orthopedic

VSP

VSP Spine System Cannulated Screw Cutter

Instrument, Cutting, Orthopedic

RZ Medizintechnik GmbH

STERNUM Plate Cutter, straight,titanium 23cm,jaws opening: 5,6mm titanium nitrite golf color coated

Instrument, Cutting, Orthopedic

Modular Radial Head (MRH) System

MRH Planar

Instrument, Cutting, Orthopedic

Curvtek Lubricant, 1OZ

Catalogue number 906744, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Global Advantage

Global Advantage Glenoid Scraper

Instrument, Cutting, Orthopedic

Exact HIP Instrumentation

Catalogue number 31-473793, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Carroll Tendon Pulling Forceps

Carroll Tendon Pulling Forceps Serrated TIP Curved Down Shaft Quantum

Instrument, Cutting, Orthopedic

DJO Surgical

SYM PAT LG 30-048-000-1650

Instrument, Cutting, Orthopedic

LCS

LCS High Performance Instruments Recut Tibial Block 2 DEG VV

Instrument, Cutting, Orthopedic

Mcindoe Bone Cutting Forceps

Mcindoe Bone Cutting Forceps Double Action Angled JAW

Instrument, Cutting, Orthopedic

Decker Rongeur, Oval 2x6mm, 15cm WL

Catalogue number 02-082-09, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

SynMesh

Synmesh® Cutter

Instrument, Cutting, Orthopedic

Salvo® Spine System

Bridge Breaker

Instrument, Cutting, Orthopedic

MatrixMANDIBLE

Matrixmandible Short CUT Plate Cutter

Instrument, Cutting, Orthopedic

Decker Rongeur, Oval 2x5mm, 10cm WL

Catalogue number 02-082-48, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Stille-Liston Bone Cutting Forceps

Stille-Liston Bone Cutting Forceps Double Crossed UP-Angle TIP Quantum

Instrument, Cutting, Orthopedic

Symmetry Littauer-Liston

Symmetry® Forceps, Bone Cutting, Straight, 6 in

Instrument, Cutting, Orthopedic

Weil-Blakesley Rongeur, Oval 2.8×2.5mm, 12cm WL

Catalogue number 07-181-27MA, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Adler Instrument Company

Ruskin Liston Bone Cutting Forceps, straight, OL 190mm (7-1/2")

Instrument, Cutting, Orthopedic

Gentle Threads Easy-OUT

Catalogue number 905654, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Global CAP CTA

Global C.A.P. CTA Cutting Block Size 52

Instrument, Cutting, Orthopedic

Novo Surgical

cervical axial cortical bone cutter, angled handle, 8-1/2" (21.0 cm), backward straight

Instrument, Cutting, Orthopedic

Symmetry McIndoe

Symmetry® Forceps, Mcindoe Bone Cutting, Straight, 7 in

Instrument, Cutting, Orthopedic

Instrument, Cutting, Orthopedic

Knee Universal Instrument Tibial Resection Block 10 Degrees

Instrument, Cutting, Orthopedic

Weil-Blakesley Rongeur, Oval 2.6×1.8mm, 30 Degrees Up, 12cm WL

Catalogue number 07-181-26MA, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Tornier Latitude

Ulnar PIN Poly Resector

Instrument, Cutting, Orthopedic

LCS Milestone

LCS Milestone A/P Resection Guide STD+

Instrument, Cutting, Orthopedic

Made-To-Order

Simpliciti Surface Planer

Instrument, Cutting, Orthopedic

Moss

Moss Miami Spine System ROD Cutter

Instrument, Cutting, Orthopedic

Silex Sacroiliac Joint Fusion System

Joint Decortication Instrument Assembly

Instrument, Cutting, Orthopedic

C-Jaws

C-Jaws Cutter

Instrument, Cutting, Orthopedic

Oxford Partial Knee SystemOsteophyte Tool

2 catalogue numbers from 32-422937, listed by Biomet UK Ltd., United Kingdom, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Ascension®

Ascension® PIP The PIP disposable pack for Linvatec/Hall includes a blade, a side burr, a planer burr, and a guide pin.

Instrument, Cutting, Orthopedic

Revision Gentle-Threads

Catalogue number 905658, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Symmetry Liston

Symmetry® Forceps, Liston Bone Cutting, Straight, 8 1/2 in

Instrument, Cutting, Orthopedic

Medline Unite

Handle, AO/QC, Ratchet, Mini, Cannulated

Instrument, Cutting, Orthopedic

Decker Rongeur, Round 2mm, 45 Degrees Up, 14cm WL

Catalogue number 02-082-20, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Spurling Rongeur, Oval 4x10mm, 16cm WL

Catalogue number 02-202-09, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 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