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

Hintermann Series

Peg Drill Talus ø 4.5 mm [Long] Instrument

Instrument, Cutting, Orthopedic

Integra®

Integra® Modular Radial Head The planar is used with the modular radial head.

Instrument, Cutting, Orthopedic

Specialist

SPECIALIST 2 MAKE TO ORDER 0 Degree Symmetrical Tibial Cutting Block with HP Connector

Instrument, Cutting, Orthopedic

Anmuth Medical International

Plate Cutt Fcps for Mini Plates to 1mm

Instrument, Cutting, Orthopedic

Stille-Horsley Bone Cutter

Stille-Horsley Bone Cutter S-Shaped UP-Angle JAW

Instrument, Cutting, Orthopedic

Kerrison Rongeur, 3mm, 40 Degrees Down, 15.5cm WL

Catalogue number 07-181-24MA, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

IdentiTi

Thin LIF Endplate Scrapers, Offset Cranial, 16mm

Instrument, Cutting, Orthopedic

General Instruments

PLIF/TLIF, BAYONETTED ENDPLATE SCRAPER, 10mm, SINGLE-SIDED 10°, RIGHT

Instrument, Cutting, Orthopedic

First Choice® Druj System

Integra® First Choice® DRUJ System The UH disposable pack for Linvatec/Hall includes a blade and two guide pins.

Instrument, Cutting, Orthopedic

Sklar®

Censitrac Ready Ruskin Rongeur CVD Side 7 1/4 IN

Instrument, Cutting, Orthopedic

Attune

Attune Knee System Revision Tibial Prep Tower Offset Bushing

Instrument, Cutting, Orthopedic

Instrument, Cutting, Orthopedic

Plate Cutter FOR 1.0MM, 1.3MM, 1.5MM, 2.0MM Plates

Instrument, Cutting, Orthopedic

Sigma

SIGMA MAKE TO ORDER 2 Degree Varus/Valgus 0 Degree Posterior Slope Tibial Cutting Block without Saw Capture

Instrument, Cutting, Orthopedic

Sigma

Sigma High Performance Fixed Reference AP Chamfer Block 2.5

Instrument, Cutting, Orthopedic

LCS

LCS Distal Femoral Resection Block 2 Degrees V/V

Instrument, Cutting, Orthopedic

Lospa Modular Knee System

Tibial Sagittal Cutting Guide

Instrument, Cutting, Orthopedic

Decker Rongeur, Oval 2x5mm, 45 Degrees Up, 14cm WL

Catalogue number 02-082-22, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Battalion

Battalion, LLIF Endplate Scrapers, Offset, Size 10

Instrument, Cutting, Orthopedic

Attune

ATTUNE MAKE TO ORDER 2 Degree Varus/Valgus 0 Degree Posterior Slope Tibial Cutting Block without Saw Capture

Instrument, Cutting, Orthopedic

PRO-TOE

VO Planar

Instrument, Cutting, Orthopedic

Columbus

Columbus 4-IN-1 Femoral Cutting Guide L7

Instrument, Cutting, Orthopedic

Newclip Instruments

54 catalogue numbers from ANC171/2, listed by Newclip Technics SAS, France, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Quinelato

Straight Luer bone rongeurs forceps 17cm

Instrument, Cutting, Orthopedic

Sigma

Sigma High Performance MI 3 Degree Handed Tibial Cutting Block Right

Instrument, Cutting, Orthopedic

Columbus Revision

Columbus REV 4-IN-1 Fem.cutting Guide F3

Instrument, Cutting, Orthopedic

Vega System PS

Vega PS 4-IN-1 Femur Cutting Guide F7

Instrument, Cutting, Orthopedic

General Instrument

Longer ALIF Double-Sided Endplate Scraper, Right/Left Bend

Instrument, Cutting, Orthopedic

Instrument, Cutting, Orthopedic

SP2 MI Femoral Chamfer CUT Block 1.5

Instrument, Cutting, Orthopedic

Integra® Jarit®

Integra® Jarit® Liston-Blau Bone Cutting Forceps 5-3/4", Straight Narrow Blades

Instrument, Cutting, Orthopedic

Intervertebral Disc Preparation Instruments

Endplate Scraper, Double Sided, Straight, Straight, 10 mm, Small

Instrument, Cutting, Orthopedic

Trocar

Catalogue number SPK03298, listed by Sontec Instruments, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Ambler Surgical

Ruskin-Roland bone cutting forceps, 7 1/4'', double-action, narrow, angled on flat, 25.0mm jaws, spring handle

Instrument, Cutting, Orthopedic

Invictus

EXCALIBUR BLADE, 20mm

Instrument, Cutting, Orthopedic

Sigma LCS

Sigma LCS High Performance EM Tibial JIG Spiked Uprod

Instrument, Cutting, Orthopedic

Univation XF

Univation XF Fem.trial/Prep.guide F1 LM

Instrument, Cutting, Orthopedic

Fusion™ Posterior Instrument Set

Curette, Ring Straight

Instrument, Cutting, Orthopedic

Micro 100

Micro 100 Reciprocator SAW

Instrument, Cutting, Orthopedic

Specialist

Specialist 2 A/P & Chamfer Cutting Block W/Removable Handle SZ 2.5

Instrument, Cutting, Orthopedic

Intuition

Intuition FOR HP Partial Femoral Finishing Block Size - Right Medial/Left Lateral 5

Instrument, Cutting, Orthopedic

Millennium

Tessier Bone Cutting forceps 7 34", one serrated cutting edge

Instrument, Cutting, Orthopedic

Integra® Miltex®

Integra® Miltex® Sauerbruch Rongeur 11-3/4", Straight, Square Bite, 16mm wide Jaws

Instrument, Cutting, Orthopedic

Rasp

Rasp, 8.8 x 260mm

Instrument, Cutting, Orthopedic

Assi

Pliers, Slip Joint; 20cm with adjustable jaw, 10mm jaw tip; max. 2" opening for Steinmann Pins, K-wires, screws & rods

Instrument, Cutting, Orthopedic

Instrument, Cutting, Orthopedic

Mini Small-Joint Scissors

Instrument, Cutting, Orthopedic

GEO-Desis

Cut Guide, GEO-Desis, 1.5mm, Single Slot

Instrument, Cutting, Orthopedic

Fusion™ Lateral Instrument Set

10 catalogue numbers from 35-RCUTTER-15, listed by Pioneer Surgical Technology, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Instrument

Tibial Offset Bushing Guide Triathlon Revision Instruments

Instrument, Cutting, Orthopedic

Hayden Medical

Ruskin Bone Cutting Forceps 7-1/2" (18.8cm), double action, delicate blades, straight

Instrument, Cutting, Orthopedic

Pneumatic AIR Hose

Catalogue number 906743, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Instrument, Cutting, Orthopedic

SP2 MI Femoral Chamfer CUT Block 2.5

Instrument, Cutting, Orthopedic

Anatomic Access Llif

Anatomic Access LLIF, Cobb, Angled CC-15°, IN, Sharp, 18mm

Instrument, Cutting, Orthopedic

Avalign

Mini Liston Bone Cutting Forcep

Instrument, Cutting, Orthopedic

Novel

Bullet-nosed Disc Shavers - 15 mm

Instrument, Cutting, Orthopedic

Nido Pedicle Screw System

Decorticating Planer

Instrument, Cutting, Orthopedic

BR Surgical, LLC

BOEHLER Bone Cutting Forceps, double action, straight, 6"

Instrument, Cutting, Orthopedic

Blustone Synergy Lumbar Shaver (Basalt, Obsidian, Magma)

The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that…

Instrument, Cutting, Orthopedic

IQ Columbus

IQ Columbus 4-IN-1 Fem.cutting Guide F7

Instrument, Cutting, Orthopedic

Integra® NuGrip®

The Finishing Shaper is used to shape the implant.

Instrument, Cutting, Orthopedic

Depuy Reach

Depuy Reach A-P Chamfer CUT Block Size 2.5

Instrument, Cutting, Orthopedic

Gimmi

Bethune RIB Shear Handles With Rubber Cover Length 340 MM

Instrument, Cutting, Orthopedic

Isola

Isola Spine System ROD Cutter (Side)

Instrument, Cutting, Orthopedic

Avalon

OCCIPITAL PLATE ROD CUTTER, 3.3-4.0mm

Instrument, Cutting, Orthopedic

Univation X

Univation X Tibia Preparation Plateau T4

Instrument, Cutting, Orthopedic

Inhance

INHANCE SHOULDER SYSTEM HUMERAL BLAZER X-LARGE diameter 44mm

Instrument, Cutting, Orthopedic

Capture™

CAPTURE™ High Torque Screw System The trocar is used during guide pin placement in the Capture high torque screw system.

Instrument, Cutting, Orthopedic

Instrument, Cutting, Orthopedic

Bone tamp - straight

Instrument, Cutting, Orthopedic

LCS Completion

LCS Completion TIBIAL CUTTING BLOCK - FULL 2 DEGREE

Instrument, Cutting, Orthopedic

LxHA™ Angled Lateral

Curette, Triangle, Angled, 13mm, SST, Silicone, Al, Adhesive

Instrument, Cutting, Orthopedic

Zimmer® Cannulated Screw System

CANNULATED COUNTERSINK, 8.2mm TRINKLE - To be used with 6.5/7.0/7.5mm Screws

Instrument, Cutting, Orthopedic

Instrument, Cutting, Orthopedic

MODIFIED INSTRUMENT RATCHETING ROD CUTTER 4.5mm

Instrument, Cutting, Orthopedic

Mondeal

Plate Cutting Forceps M1/M2

Instrument, Cutting, Orthopedic

Stille Bone Cutters

BONE CUTTING FORCEPS ORIGINAL STILLE curved 19 cm 7.5 in

Instrument, Cutting, Orthopedic

Gentle Threads™

6 catalogue numbers from 905651, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

NuGrip® CMC Implant System

Integra® NuGrip® The CMC disposable pack for Stryker includes a blade, a 5mm spherical burr and an 8mm spherical burr.

Instrument, Cutting, Orthopedic

Vega

Vega A/P 4-IN-1 Cutting Block F8

Instrument, Cutting, Orthopedic

Weil-Blakesley Rongeur, Oval 2.2×1.9mm, 12cm WL

Catalogue number 07-181-25MA, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Arthrex®

iBal UKA, Disp Tib Cut Guide, Right

Instrument, Cutting, Orthopedic

Actis

Actis Neck Resect Guide, Right

Instrument, Cutting, Orthopedic

S-ROM

S-ROM MI Triangle Miller Cutter Size 20

Instrument, Cutting, Orthopedic

S-ROM

S-ROM Triangle Miller Cutter, Violet Size 12

Instrument, Cutting, Orthopedic

Disc Preparation Instruments

LIF, ENDPLATE SCRAPER, SS, 10mm

Instrument, Cutting, Orthopedic

Endiscope and Accessories

Dia: 3.0mm, Length: 310mm

Instrument, Cutting, Orthopedic

Obturator

Catalogue number SPK03297, listed by Sontec Instruments, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

NuGrip CMC

Cannulated Spherical Cutter SZ. L

Instrument, Cutting, Orthopedic

Specialist P.F.C. Sigma

Specialist 2 P.F.C. Sigma A/P & Chamfer Cutting Block W/Removable Handle SZ 6

Instrument, Cutting, Orthopedic

Pilling

5 catalogue numbers from IPN017477, listed by Teleflex Medical LLC, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Conmed

Wiredriver Chuck Adapter

Instrument, Cutting, Orthopedic

Columbus PS

Columbus PS Femoral BOX Prep.guide F1

Instrument, Cutting, Orthopedic

Oxford® Partial Knee SystemOsteophyte Removal Tool

2 catalogue numbers from 32-422939, listed by Biomet UK Ltd., United Kingdom, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

V. Mueller

V. Mueller LISTON-STILLE TYPE DOUBLE ACTION BONE CUTTING FORCEPS STRAIGHT OVERALL LENGTH 10-1/2 inches 26.7CM

Instrument, Cutting, Orthopedic

Construct®

Construct® Ankle Fusion Plate System The Smith Peterson straight osteotome is used for cutting bone.

Instrument, Cutting, Orthopedic

MSI Precision Specialty Instruments

Ruskin-Liston Bone Cutting Forceps, Straight, Delicate Blades, Double Action, Spring Handle, Overall Length 7-1/2" (191mm)

Instrument, Cutting, Orthopedic

Ocelot

Ocelot Stackable Cage System Angled M3 Screw Cutter

Instrument, Cutting, Orthopedic

Capture High Torque Screw System

Catalogue number TRC-5000-507-070, listed by Smith & Nephew, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Raw Surgical Corporation

RUSKIN BONE SPLITTING FORCEPS, Straight blades, Double-action, Overall length 71/4" (18.4cm)

Instrument, Cutting, Orthopedic

Liston Bone Cutting Forceps

Liston Bone Cutting Forceps Double Action UP-Angle TIP

Instrument, Cutting, Orthopedic

Surgipros

Saurbruch RIB Shears 10 1/2" Straight

Instrument, Cutting, Orthopedic

Tornier Simpliciti

Surface Planer

Instrument, Cutting, Orthopedic

Bethune-Coryllos RIB Shears

Bethune-Coryllos RIB Shears Left Sided Blade

Instrument, Cutting, Orthopedic

PyroCarbon PIP Total Joint System

PIP Disposable Pack FOR Linvatec/Hall

Instrument, Cutting, Orthopedic

Evolve Proline

Proline Neck Planer

Instrument, Cutting, Orthopedic

Decker Rongeur, Oval 2x5mm, 14.5cm WL

Catalogue number 02-082-23, listed by Mizuho America, Inc., United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Solanas

3.3mm ROD CUTTER

Instrument, Cutting, Orthopedic

Arthroscopic Metzenbaum Hook Scissors

Arthroscopic Metzenbaum Hook Scissors With Overload Cone Right Angled TIP

Instrument, Cutting, Orthopedic

Columbus

IQ Columbus A/P 4-IN-1 Cutting Guide F3

Instrument, Cutting, Orthopedic

Attune LCS

ATTUNE LCS MAKE TO ORDER STYLE ANTERIOR POSTERIOR CUTTING BLOCK Size 10

Instrument, Cutting, Orthopedic

Axle Interspinous Fusion System

Interspinous Ligament Piercer Assy, Axle System

Instrument, Cutting, Orthopedic

Quick Click Rotatable Handle

Quick Click Rotatable Handle With Integrated Spring

Instrument, Cutting, Orthopedic

L-Box®

SST, Al

Instrument, Cutting, Orthopedic

Arthrorivet(TM) Inserter

Catalogue number 905806, listed by Biomet Orthopedics, United States, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Titan™

Titan™ Total Shoulder System The osteotome is an instrument used for cutting bone in conjunction with the Titan Total Shoulder System.

Instrument, Cutting, Orthopedic

Spirecut

2 catalogue numbers from KIT-SI-TF-01.01, listed by Spirecut SA, Switzerland, under Instrument, Cutting, Orthopedic. 11 manufacturers in China are registered for this product code.

Instrument, Cutting, Orthopedic

Global Steptech APG

GLOBAL STEPTECH APG SCRAPER SUPERIOR / INFERIOR +5mm RIGHT

Instrument, Cutting, Orthopedic

Decker Rongeur, Oval 2x5mm, 45 Degrees Up, 11cm WL

Catalogue number 02-082-49, 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 High Performance

Sigma High Performance MI 0 Degree Handed Tibial Cutting Block Right

Instrument, Cutting, Orthopedic

Rib Shears

Constable Rib Shears With Finger Lock

Instrument, Cutting, Orthopedic

Global Icon

GLOBAL ICON Stemless Shoulder System HUMERAL PUNCH Size 46

Instrument, Cutting, Orthopedic

Evolve

EPS Plate Cutter

Instrument, Cutting, Orthopedic

Inhancetm

Inhancetm Make TO Order Intramedullary Humeral Resection Guide Right

Instrument, Cutting, Orthopedic

Titan Modular Shoulder System 2.5

TSS Implant Calcar Planer. 2.5

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