Rongeur

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Shanghai, Shandong and Jiangsu, and 1 other province: 11 hold an FDA registration. 3 are contract manufacturers.

B.Braun Medical (Suzhou) Co,.Ltd Jiangsu, contract manufacturer
Beijing Fule Science & Technology Development Co., Ltd. Beijing
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Jiangsu, contract manufacturer
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Qingdao Zhixing Medical Instrument Co., Ltd. Shandong
Shanghai Kangqiao Dental Instruments Factory Shanghai
Shanghai KiNETIC Medical Co Ltd Shanghai, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Xinhua Healthcare Industry Co., Limited Shandong, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

How Is HTX Classified?

Rongeur is FDA product code HTX, 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 Do the Recalls Say?

The FDA has recorded 7 recalls under this product code since 2017. None was by a company in China. The root cause the FDA records most often is Error in labeling (6).

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

SpineEx

Kerrison Rongeur, Straight

Kleineright-Kutz Duckbill Synovectomy Rongeur

Kleineright-Kutz Duckbill Synovectomy Rongeur Double Action Curved TO Side JAW

Osteotomy Instruments

LIF Double Action Rongeur, 12mm

SeaSpine Spacer System – Hollywood

Up-Angled Pituitary, 5mm

Kerrison Handle Black Coated

Catalogue number 404-606B, listed by Sontec Instruments, Inc., United States, under Rongeur. 11 manufacturers in China are registered for this product code.

T.l.i.f.

T.L.I.F. SG INSTRUMENTS PITUITARY RONGEUR, STRAIGHT 2mm

Cup Forceps, up Angled

Cup Forceps, Up Angled, 2.0 x 330mm

Bailey Aortic Valve Rongeur

Bailey Rongeur

DA Anterior Rongeur

DA Anterior Long Straight Rongeur 12mm

TAP-LIF Instruments

STRAIGHT RONGEUR 4mm

Kerrison Rongeur Forward Cutting 3mm/18cm

A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open A hand-held…

Echlin Bone Rongeur

Echlin Bone Rongeur 2mm Jaw 23cm

Beyer Rongeur

Beyer Rongeur Double Action Curved JAW

Sq.line

Bone Rongeur Very Strong LAT-ANG 240MM

OrthoMedFlex

Sypert Bone Rongeur

Leksell Bayonet Shaped Rongeur

Leksell Bayonet Rongeur Right Angled JAW

Kerrison Punch Rongeur

Kerrison Punch Rongeur Down Angle TIP

Takahashi Rongeur

Takahashi Rongeur Oval CUP JAW Straight Shaft

Snowden-Pencer

Snowden-Pencer RONGEUR TEBBETTS 17CM 6-3/4 inches, 2.5 MM JAW

Snowden-Pencer

Snowden-Pencer KLEINERT-KUTZ FORCEPS STRAIGHT TIP OVERALL LENGTH 5-1/2" (14CM)

Stryker

Pituitary Up-biting 4mm, Non-Bayonetted

Spurling Pituitary Rongeur

Spurling Pituitary Rongeur Down Angled Shaft

Adson Rongeur 20cm Str

Catalogue number 12-037-20, listed by N S Surgical Company, under Rongeur. 11 manufacturers in China are registered for this product code.

Knee Osteogator

Knee Osteogator: 1 catalogue number listed by Signal Medical Corp., United States, under Rongeur. 11 manufacturers in China are registered for this product code.

Kalitec Disc Prep

Pituitary, Up Biting, 3mm

Surjex

Extra Long Rongeur, Overall length 14", 5x16mm jaw Bite

Whitcomb-Kerrison

Whitcomb-Kerrison Rongeur Right Angled Bite

Ferris Smith Wilde Rongeur

Ferris Smith Wilde Rongeur Straight TIP

Regatta

Osteophyte Biter

Atec Instruments

Pituitary Rongeur, UP Biting, 4MM

Rottgen-Ruskin Bone Rongeur

Rottgen-Ruskin Bone Rongeur 24cm

Intervertebral Body Fusion Device

Catalogue number ALN028, listed by Precision Spine, Inc., United States, under Rongeur. 11 manufacturers in China are registered for this product code.

Leksell Bone Rongeur

Small Leksell Bone Rongeur 3mm Jaw 17-1/2cm

Rasp

4 catalogue numbers from 11-2812, listed by Elliquence LLC, United States, under Rongeur. 11 manufacturers in China are registered for this product code.

CSU Blumenthal Rongeur

Catalogue number 1100-575, listed by Sontec Instruments, Inc., United States, under Rongeur. 11 manufacturers in China are registered for this product code.

Forceps – Rongeur for Cement Extraction (Slide Measures 205mm) – 20mm Jaw Width

Catalogue number PN2321, listed by Platts & Nisbett Limited, under Rongeur. 11 manufacturers in China are registered for this product code.

LIF Revision Instruments

LIF, Pituitary Rongeur, Bayonetted, 7mm

Cougar

COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM ANGLED PITUITARY, RIGHT 6mm

Weil CUT-Through Rongeur

Weil CUT-Through Rongeur UP-Angle TIP Scissor Action Fenestrated JAW Quantum

Anatomic Access Llif

Anatomic Access LLIF, Angled CC-15° Rongeur, Right, 3mm

Adson Bone Rongeur

Modified Deep Adson Bone Rongeur Angled 26cm

Friedman Rongeur

Friedman Rongeur Miniature Straight TIP

ActivL

Kerrison 4.0MM 90DEG 310MM

Kerrison UP-Angle Rongeur

Kerrison Rongeur UP-Angle Bite

Kerrison Ronguer

Convertible Kerrison Ronguer With Ejector Pin 10 Millimeter Opening 40° Up-Angle 5 Millimeter Bite

Micro Friedman Rongeur

Micro Friedman Rongeur Full Curved TIP Ring Handle

McILWRAITH Rongeur

McILWRAITH ARTHROSCOPIC SCISSORS RONGEUR SERRATED TIP

Tontarra Medizintechnik GmbH

PITUITARY Rongeur straight; 2mm width; coated 230mm (9.2")

Sypert Rongeur

Sypert Rongeur Curved Extended JAW

Rongeur

Echlin Duckbill Rongeur Stainless Steel 3X10MM CUP 229MM

Vital Spinal Fixation System

Vital Underbiting Rongeur

Kerrison Rongeur Punch 5mm Jaw, Length 200mm With 40 Degree up Bite

Catalogue number KRU1501, listed by DTR Medical Ltd, United Kingdom, under Rongeur. 11 manufacturers in China are registered for this product code.

BR Surgical, LLC

MICRO FRIEDMAN Rongeur, slight curve, 2.0mm, delicate, 5 1/2"

Symmetry Reiner

Symmetry® Rongeur, Reiner, 3.0 mm Bite, 7 in

Black Ceramitic Kerrison Rongeur

Black Ceramitic Kerrison Rongeur 40 Degrees

Anmuth Medical International

Micro Kerrison Ejector Ronguer, thin footplates, 40 degrees up, 5mm bite, ceramic coated, 20cm/8"

Symmetry Jansen

Symmetry® Rongeur, Jansen, Bayonet Shaped, 4.0 mm Wide Jaws, 6 3/4 in

Beyer Double Action Rongeur 18cm

Catalogue number 12-040-18, listed by N S Surgical Company, under Rongeur. 11 manufacturers in China are registered for this product code.

Pipeline

PIPELINE ACCESS SYSTEM 40 DEGREES KERRISON RONGEUR 3mm

Sontec Lempert Rongeur

Sontec Lempert Rongeur Straight TIP

Rongeur

Bernstein Forceps; Septal, Arched, Carbide JAW, 8 1/4" (21CM)

Zaufel-Jansen Rongeur

Zaufel-Jansen Rongeur Double Action Strong Curved JAW

McILWRAITH Basket Cutter Rongeur

2 catalogue numbers from 1404-857, listed by Sontec Instruments, Inc., United States, under Rongeur. 11 manufacturers in China are registered for this product code.

L-Box®

12 catalogue numbers from LB-161, listed by Inno-Health Technology Co., Ltd., Taiwan, under Rongeur. 11 manufacturers in China are registered for this product code.

GEN2

Friedman Rongeur, 2.5mm curved jaw, 5 1/4" (13cm)

Symmetry Surgical

Symmetry® Rongeur, Pituitary Bayonet, Angled Up, 2.0 mm X 8.0 mm, Ceramic, 160 mm Working Length

Stille-Luer Rongeur

Stille-Luer Rongeur Double Action Curved 17 x 23 Millimeter Jaw

AMP-LTX

Osteophyter

Illico

ILLICO 2mm FORAMANOTOMY KERRISON. BAYONETED

Ruskin-Liston Bone Cutter

Ruskin-Liston Bone Cutter Straight 18.5cm

Ruskin Bone Rongeur 18cm Cvd

Catalogue number 12-043-18, listed by N S Surgical Company, under Rongeur. 11 manufacturers in China are registered for this product code.

Leksell Duckbill Rongeur

Leksell Duckbill Rongeur Double Action 50 Degrees Full Curved 6 Millimeter x 16 Millimeter Jaw

VEO® Lateral Interbody Fusion System

LATERAL,RONGEUR,PITUITARY,6

Rongeur

Peapod Forceps Rongeur Up-Angled 3.2mm 18cm Long

Scanlan® Rongeur

SCANLAN® MEMORY Blade and blade tool

Echlin Duckbill Rongeur

Echlin Duckbill Rongeur Double Action Curved To Side 3 Millimeters X 12 Millimeters Quantum

Integra® Miltex®

Integra® Miltex® Ferris-Smith Pituitary Rongeur 7" Shaft, Cup Jaws, 3mm x 10mm Bite, Up-Angled

Weil Blakesley Rongeur

Weil Blakesley Rongeur With Suction Straight TIP Round Eliptical Fenestrated JAW

Disc Prep

Bayonet Pituitary Rongeur 2mm Upbiting (02-0242)

Bailey Rongeur

Bailey Rongeur Down Angled TIP

Lempert Rongeur

Classis Lempert Rongeur Straight JAW Quantum

Excella II®

2 catalogue numbers from LS-191, listed by Inno-Health Technology Co., Ltd., Taiwan, under Rongeur. 11 manufacturers in China are registered for this product code.

T.l.i.f.

T.L.I.F. SG INSTRUMENTS PITUITARY RONGEUR, STRAIGHT 4mm

Decker Micro Rongeur

Decker Micro Rongeur Angled Up 2 Millimeter x 6 Millimeter Bite

Rongeur

Kerrison 40 degree 3mm

Rongeur

4x10mm Pituitary Rongeur, Serrated Teeth, 30° Upward Angled

Elmed Incorporated

Kerrison Rongeur, Micro, 8" (200mm), 1.5mm, 40° up, Super Coat, Cervical

Spinal Pro Rongeur

Spinal Pro Multi-Bite Kerrison Rongeur 5.2mm x 40 Degree, 15"

Posterior Disc Prep

Kerrison, 40 Deg Up Bite 3mm

Spira-A

Ferris Smith Pituitary Rongeur, Straight, 12", 2mm Tip, No Teeth, DLC Coating

FlareHawk

Pituitary, Straight 3mm, FH7 MIS2

Deep Anterior DA Rongeur

Deep Anterior Double Action Rongeur 6-1/2mm 30cm long

Scissor Punch

Scissor Punch, Up Angle 3.5 x 260mm

Rongeur

CERAMO FERRIS-SMITH rongeur, cutting, straight, graduated, 4.0 x 300 mm

Symmetry Ruskin-Liston

Symmetry® Forceps, Ruskin-Liston Bone, Straight, 7 1/4 in

Resource

MG Boehler Rongeur Wide Dblact 5MM 160MM

Elite Medical Instrumentation

Love-Gruenwald Rongeur, Down Bite, 3x10mm, 180mm

Schlesinger Rongeur

Schlesinger Rongeur 6.0 Inches X 2 Millimeters Up Bite

D.A. Hoag Rongeur

D.A. Hoag Rongeur 7mm Bite, 24cm Length

Rongeur

24 catalogue numbers from 3317, listed by Zimmer, Inc., United States, under Rongeur. 11 manufacturers in China are registered for this product code.

Solitaire Cervical Spacer System

ADI Pituitary Rongeur STR 5MM

Valve XS

VALVE XS Rongeur, 30 °, angled upwards (370 mm), working length: 290 mm , jaw length: 10 mm, jaw width: 3 mm

Kerrison Bayonet Rongeur

Kerrison Bayonet Rongeur Without Ejection PIN Angled TIP Thin Footplate Black Ceramitec Coated

Smith-Peterson Laminectomy Rongeur

Smith-Peterson Laminectomy Rongeur Stout Model Slight Curve JAW

Bone Graft Cutter

Bone Graft Cutter w/Depth Control 10mm

Irix-A Lumbar Integrated Fusion System

Irix A 4mm Anterior Kerrison Rongeur

Impix 3d Print

Disc rongeur, Angled Up 2mm

Stille Bone Rongeurs

BONE RONGEUR ORIGINAL LEKSELL-STILLE curved narrow jaws 24 cm 9.5 in

Foramenotomy Rongeur

MIS Low Profile Foramenotomy Rongeur 3mm x 40 Degree 8"

Cleveland Rongeur

Cleveland Rongeur 2.5 Millimeter Curved Jaws

Symmetry Cushing

Symmetry® Rongeur, Cushing, Straight, 6 mm Wide, 8 in, 203 mm

Pituitary Rongeur

Anterior Intervertebral Pituitary Rongeur Up-Angled 2mm, 11-1/2" 29.6cm

Ferris Smith Arthroscopic Rongeur

Ferris Smith Arthroscopic Rongeur Straight Shaft Black Ceramitec Coated

Punch, Vascular, Acc. Geister 4.0 X 135mm

Catalogue number 21-0604, listed by Geister Medizintechnik Gmbh, Germany, under Rongeur. 11 manufacturers in China are registered for this product code.

Kamiyama

Micro Rongeur, Double link, Curved 30 deg neck, 1.5mm Blades width

Rongeur

8 catalogue numbers from 09-0178, listed by Biomet Microfixation, United States, under Rongeur. 11 manufacturers in China are registered for this product code.

Ace Medical Co

Black Caspar-style IVD Rongeur w/teeth, 4mm straight, 11"

General Instrument

2x10mm Right Angled Pituitary w/ Scissor Style Handle Grip

3DP Lumbar Interbody System

Toothless Double Action Rongeur

Beatty Foraminotomy Rongeur

Beatty Foraminotomy Rotating Kerrison Rongeur With Shaft Lock AND Tissue Ejector PIN Curved Down

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