Mallet

Which Manufacturers in China Make This?

6 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Shanghai and Guangdong, and 1 other province. 2 of them are contract manufacturers, able to build to a buyer’s own specification.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong

What Is FDA Product Code HXL?

Mallet is FDA product code HXL, 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 1 recall under this product code since 2021. None was by a company in China. The root cause the FDA records most often is Device Design (1).

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

Collin Lucae Mallet

Collin Lucae Mallet Solid Head

MSI Precision Specialty Instruments

Phenolic Handle Mallet Slotted Medium Cylinder Shaped Head With Wide, Double Sided Flat Face, Overall Length 9 1/2" (24.3cm), Head Diameter 1.18" (30.0mm), Overall Weight 14.1 oz., Handle…

Integra® Jarit®

Integra® Jarit® Nasal Mallet, 7-1/4", With 2 Nylon Caps, 4 Oz Head Weight, Aluminum Handle

General Instruments

Inserter Slap Hammer Adapter - Improved Active Lock

Tecomet

Mallet Light Chrome HANDLE-1 LB 2 OZ/8 OZ

Calix Spinal Implant System

Specialty Short Stroke Slide Hammer Assembly

Tornier Simpliciti

Catalogue number 9722938, listed by Tornier Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

Surgical Direct

Nylon Cap Replacement for SD914556102 7 1/2 Mallet, 7-1/2 9 oz. (255 G), Stainless Head 1 Diameter, with One Stainless Face and One Replaceable Nylon Cap

Medical Products Resouce

8.75" Slotted Mallet

Mallet

Hammer Guide FOR Slide/Fixed Hammer 400 Grams

Hayden Medical

Hayden Mallet 7-1/2" (18.8cm), 9oz. (255 grams) stainless head, 1" (2.5cm) head with one stainless face & one replaceable nylon cap

Millennium

Lightweight Combination Mallet oz diameter length . round handle

Timberline Lateral Fusion System

Lateral Slap Hammer Adapter

Mallet

8 catalogue numbers from 155-01, listed by Zimmer, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

Main-Mallet

Single-Use, Mallet, 8" Slotted, Small Contoured Handle, 16oz Head Weight, Sterile

Nylon Spare Facings

for metal mallet 25 mm, 1 pair

RZ Medizintechnik GmbH

Smith Peterson Mallet Ø38mm, with brass head, 165mm with aluminium handle, 282g

Alamo P, Alamo T

Slotted Mallet Instrument

Mallet

Mallet With Hardened Removable Stainless Steel/Nylon Head

Slotted Mallet

6 catalogue numbers from 471346, listed by Biomet Orthopedics, United States, under Mallet. 6 manufacturers in China are registered for this product code.

Bone Mallet

Bone Mallet AO Type Phenolic Handle

Aesculap

WAGNER Mallet, 9 1/4" (240 mm), diam. 35 mm, peek handle, stainless steel, consisting of FL064R, FL065, 690 g, 340 g, Set

Generic Surgical Instruments

Mallett,325G, Plastic Strike Plate Inserts

Integra® Miltex®

Integra® Miltex® Mallet 7-1/2", Head: Weight 7.5oz., Diameter 1", 2 Polyacetal, Polyoxymethylene Caps

Princeton

Mallet ONE Interghangeable Plastic Disc (ONE Side Steele 25MMØ 230G (.50LBS) Aluminium Handle 7.25"

Spinal Mallet

Spinal Mallet Steinback Handle

Centurion Medical Products Corp

Sterile Mallet

Sq.line

Mallet 530GR.HEAD W/Exchangeable Disks

Metal Mallet

with convertible nylon facings 25 mm, 220 g, 18.5 cm

J&J Instruments

Mallet #49 7.5"" Lead-Faced

Battalion

Slap Hammer, Long, Heavy

Gsource

gSlap Hammer, 10 1/2", 700g, 5/16-18-UNC-2A Thread for Sierra Disc Prep Set

Streamline® MIS Spinal Fixation System

Streamline MIS, Mallet

Slap Hammer

A hammer with a mobile mass can be attached to the extraction clamp, as well as on the hook. It permits to give the necessary impact to extract the knee implants. This is a reusable device.

Medicon

Mead mallet w plastic facings Ø 26mm 300g 18cm

Osung MND

A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in…

Mallet

Nylon/Stainless Steel Mallet; 7 1/4''(18.5CM), 7OZ Head

Calix P

Calix P Specialty Slap Hammer

Marina Medical

Orthopedic Mallet, Solid Stainless Steel head, 10.75” (27.5cm), 3lbs

Symmetry Hajek

Symmetry® Mallet, Hajek Bone, Solid, 1 in Head, 6 1/2 oz Weight, 8 1/4 in, 209 mm

Vault C Acdf System

Impaction/Extraction Mallet

Solitaire Cervical Spacer System

Soli-C Slotted Mallet Head

Spinal System

Catalogue number 132M1001, listed by Biomet Spine, United States, under Mallet. 6 manufacturers in China are registered for this product code.

Endoskeleton™ TCS Interbody System

Mallet 5210-1003 TCS Mallet

Sontec Mallet

Sontec Mallet Large Size With Removeable Steel/Nylon Heads

TC-Plus / RT-Plus

TC REV/RT/RT MOD. Slap Hammer

Illico

Catalogue number 73702, listed by Alphatec Spine, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

Swanson

Catalogue number 61360100, listed by Wright Medical Technology, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

Telluride MIS Spinal Fixation System

Mallet Cann

Trinica/Trinica Select Anterior Cervical Plate System

Slap Hammer Hahn PLIF

Intervertebral Disc Preparation Instruments

Slap Hammer, Standard

AlloWedge

Mallet - Foot and Ankle Wedge

Dakota Alif System

Catalogue number 69-IN-0084, listed by Precision Spine, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

Replacement Heads for Mead Mallet

Replacement Heads for Mead Mallet Per Pair

Kmedic

Bergman Mallet 9 1/2" 17 OUNCE/11 Ounce

Irix-A Lumbar Integrated Fusion System

Irix A Mallet/Extractor

HU-Friedy

Nylon Facing FOR #1 Mallet German Style

Precice® Intramedullary Limb Lengthening System Instrument

Orthopedic surgical instrument (mallet) - for use with the intramedullary limb lengthening system

BR Surgical, LLC

BR Mallet with interch.nylon inserts Ø25mm, 5 ounce (140g), 7 1/4"

Mallet

Catalogue number 430030, listed by Biomet Orthopedics, United States, under Mallet. 6 manufacturers in China are registered for this product code.

V. Mueller

V. Mueller KIRK MALLET HEAD DIAMETER 1-1/2 inches 3.8CM WEIGHT 26 OZ 737.8G OVERALL LENGTH 7-3/4 inches 19.7CM

Benco

Mallet #49 7.5" Lead Filled

J & J Instruments Inc

Mead Mallet 7.5"" Rubber-Faced

Pediflex

PediFlex Forked Mallet

Main-Mallet-Spinal Simplicity

Single-Use, Surgical Mallet, Slotted, 8" Small Contoured Handle, 16oz Head Weight, Spinal Simplicity, Sterile

Nylon Head for Deluxe Mallet

Nylon Head For Deluxe Mallet Model 1

Atec Instruments

Hammer, Impact

SureLOK Pedicle Screw System

SureLOK MIS Mallet

PDT, Inc.

T869 Mallet (180g)

General Instrument

1/2lb. Mallet

Mallet

2 catalogue numbers from 324-0023, listed by OsteoCentric Technologies,Inc, United States, under Mallet. 6 manufacturers in China are registered for this product code.

Hajek Metal Mallet

200 g 20 cm

Nylon Head

Nylon Head FOR Mallet 1.0 Inch 1100-461

Natural Nail®

Catalogue number 00-2490-032-05, listed by Zimmer, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

ActivL

Mallet W/Exchangeable Disks

Pomee

Mallet#49 7 1/2" 2oz Lead filled head steel faced

ZMS®

Catalogue number 2237-05, listed by Zimmer, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

Impact

Mallet The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate…

Deluxe Mallet

Deluxe Mallet With Stainless Steel/Nylon Head

Disc Preparation Instruments

Catalogue number 132M1001, listed by Highridge Medical, LLC, United States, under Mallet. 6 manufacturers in China are registered for this product code.

Replaceable Nylon Head

Replaceable Nylon Head FOR Mallet

Target Endoscopic Instrument

[Target] TML0001 Mallet

Vyrsa General Instrument

Catalogue number VY-104-098, listed by Vyrsa Technologies, under Mallet. 6 manufacturers in China are registered for this product code.

Irix-C Cervical Integrated Fusion System

Catalogue number T066-0195, listed by Xtant Medical Holdings, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

Henry Schein

Mallet Surgical Steel Face

Solus

Solus Slap Hammer

Disruptive MedTech

Mallet, 11.5x20mm head, 432g

Silex Sacroiliac Joint Fusion System

Mallet / Extractor Assy

Rumex

Surgical Mallet, Polished Finish, Stainless Steel

Stille Mallets

MALLET phenolic handle stainless steel head with Teflon insert 17 cm 6.75 in

Darby Dental Supply, LLC

Mallet Surgical SS Darby

Pacific Instruments

Hajek Mallet

Xsert Lumbar Expandable Interbody System

Catalogue number T092-1900, listed by Xtant Medical Holdings, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

Integrate-C

Catalogue number Mallet, listed by Happe Spine, United States, under Mallet. 6 manufacturers in China are registered for this product code.

Mallet

Catalogue number ARS744500, listed by Tornier Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

Mead Mallet

Mead Mallet With Double Nylon Head

Removable Stainless Steel Head for Mallet

Catalogue number 330-824SH, listed by Sontec Instruments, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

A-Box®

Mallet Assembly, Ti 6Al 4V, SST

General Instrument

Llif Implant Slide Wide, Tracked, Slap Hammer

Spira-C Integrated

Catalogue number SCZ-104-300, listed by Camber Spine Technologies, United States, under Mallet. 6 manufacturers in China are registered for this product code.

Mallet

Catalogue number 45-041, listed by Hankil Tech Medical Co., Ltd., South Korea, under Mallet. 6 manufacturers in China are registered for this product code.

Mallet

Catalogue number 11-2511, listed by Elliquence LLC, United States, under Mallet. 6 manufacturers in China are registered for this product code.

Affixus®

Catalogue number 211308008, listed by Zimmer, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

Cottle Mallet

18 cm

AlloWedge

Catalogue number 55-MALLET, listed by Pioneer Surgical Technology, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

TM Ardis Interbody System

Slaphammer

Bausch + Lomb

Mallet Mastoid Lead Filled

4WEB Medical

Catalogue number PSTS-000060, listed by 4WEB Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

Medtronic Reusable Instruments

Instrument 907-404 Tangent Mallet

Zyston Interbody Spacer System

Zyston Slotted Mallet

Symmetry Hibbs

Symmetry® Mallet, Hibbs, 1 1/2 in x 8 in, Solid Brass Head, Weight 12 oz

250mm Mallet

Catalogue number 2004-0131, listed by OsteoCentric Technologies,Inc, United States, under Mallet. 6 manufacturers in China are registered for this product code.

Symmetry Ochsner

Symmetry® Wire Twister, Ochsner

Mergence-A Preparation Instrumentation

Catalogue number 07.01237.001, listed by Highridge Medical, LLC, United States, under Mallet. 6 manufacturers in China are registered for this product code.

Trauma Fixation Systems

Catalogue number 14-442053, listed by Biomet Orthopedics, United States, under Mallet. 6 manufacturers in China are registered for this product code.

Elite Medical Instrumentation

Cottle Mallet, 184mm

Redemption

Catalogue number RD-MLT, listed by Vilex LLC, United States, under Mallet. 6 manufacturers in China are registered for this product code.

Sampedro

Cottle mallet φ30mm

M/DN®

Catalogue number 2237-60, listed by Zimmer, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.

Stainless Steel Head for Mallet

Stainless Steel Head for Mallet 1.0 Inch 1100-462S

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