Awl

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shandong and Shanghai, and 3 other provinces: 13 hold an FDA registration. 4 are contract manufacturers.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
Beijing Fule Science & Technology Development Co., Ltd. Beijing
Bothwin (Beijing) Medical Technology Co., Ltd. Beijing
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Jiangsu, contract manufacturer
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Shandong Weigao Orthopaedic Device Co., Ltd. Shandong, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Shanghai Reach Medical Instrument Co., Ltd. Shanghai
Suzhou Endophix Co., Ltd. Jiangsu
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 HWJ?

Awl is FDA product code HWJ, 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 26 recalls under this product code since 2020. None was by a company in China. The root causes the FDA records most often are Device Design (24), Process design (1) and Nonconforming Material/Component (1).

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

HNM Medical

Highflow Operating Sheath, LG Suct Irrigation Perf, 2 Stopcock, 6.5MM, Yellow

MicroFrance®

MicroFrance® Square pick 5.0mm tip 165mm length

Awl

Awl, 16.0cm

Millennium

Rotator Cuff Awl Ergonomic Radel Handle . prong depth OL . handle legnth

Metha

Metha AWL F/Opening Medull.canal Large

Awl

MAKE TO ORDER Starter Awl RIGHT

V. Mueller

V. Mueller OBWEGESER-TYPE AWL SLIGHTLY CURVED OVERALL LENGTH 5-1/2 inches 13.9CM

Synfix Evolution

Synfix® Evolution AWL/Without Sleeve

Brickyard Stand-Alone Alif

Torque-Limiting Handle AO Male Connection

OsteoFab Suture Anchor

4mm OsteoFab Suture Anchor Awl

Aspiron™ ACP System

4 catalogue numbers from NC7210, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Solitaire Cervical Spacer System

Soli-C Drill/AWL Spring Sleeve

Alcantara Thoracolumbar Plating

Bevel Tip Awl, Straight

Irix-A Lumbar Integrated Fusion System

Specialty Irix A Fixed Angle Guided AWL Assembly

Avalign

Square Tip Awl With Metal Handle Small OL225mm (8 7/8")

Trial Punch

Catalogue number 17786, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Alta Acdf System

Timberline Anchored Lateral Retractable Awl

P.l.u.s.®

SQUARE AWL with silicone handle

Silex Sacroiliac Joint Fusion System

Specialty Jamshidi Awl Insert

General Instruments

AWL TAP Handle, TWO Piece Stylet Wire, Diamond

Mega Spine System

2 catalogue numbers from 51640-04, listed by BK Meditech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

MSI Precision Specialty Instruments

Bankart Percussion Awl, Curved, Round 15/16" (24.8mm) Diameter Head, Square Shaped Body, Overall Length 8-7/8" (225mm)

NewPort

MIS Double Lead Awl/Tap 6.0mm (For 6.5mm screw)

Velofix™ SA Cervical Cage

6 catalogue numbers from TS0060, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Generic Surgical Instruments

Awl, Ball-Joint, 1/4" QC, L20 Tip. DTS Compatible

Awl

8 catalogue numbers from 01-7826, listed by Biomet Microfixation, United States, under Awl. 13 manufacturers in China are registered for this product code.

Arcadius XP C

Arcadius XP C Fixed Angle Bone AWL

Inion Spine Instrumentation

Inion Spine instrumentation: 2 catalogue numbers listed by Inion OY, Finland, under Awl. 13 manufacturers in China are registered for this product code.

Gsource

Bone Awl (Lenke-style) 9 1/2", diamond tip, silicone teardrop II hdl, green, with end cap

Instrument

10 catalogue numbers from Awl cannulated, listed by Signus Medizintechnik Gmbh, Germany, under Awl. 13 manufacturers in China are registered for this product code.

General Instrument

Bone Awl Short Tip

Quantum® Spinal Fixation System

5 catalogue numbers from 10-AWL-18, listed by Pioneer Surgical Technology, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Microfracture Pick

4 catalogue numbers from 909106, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

AWL

Round Handle, 2.5 MM Diameter TIP

Tryptik Instrumentation

Catalogue number MOS-IN 00 01-N, listed by Spineart SA, Switzerland, under Awl. 13 manufacturers in China are registered for this product code.

Silicone PIP

Starter AWL Assembly

Apex

Ø12 Cannulated Curved Awl

Awl

CEMENT SPLITTER 8mm x 13in

AWL

Chondral Pick 45 Degree

General Instrument

Spring Loaded AMP Angled Awl - 15mm

Medtronic Reusable Instruments

Instrument 9339004 Staple Guide Thoracic

Omega

4.75MM Omega TAP

Scarlet AL-T-Instruments

SUJ AWL

Quick Connect Ball Joint Awl

Catalogue number RO0037QBJA, listed by Spineup Inc, United States, under Awl. 13 manufacturers in China are registered for this product code.

Awl

Cannulated AWL W/1.8MM Cannula F/5.0MM & 6.0MM & 7.0MM Screw

Irix-C Cervical Integrated Fusion System

Specialty Irix C Fixed Angle AWL Moveable Sheath

Punch Awl

Catalogue number RO0017PASZ, listed by Spineup Inc, United States, under Awl. 13 manufacturers in China are registered for this product code.

Bengal

Bengal Stackable Cage System Extra Large AWL Guide

Surgical Instrument

4.75 Bone Awl (Disposable)

Scarlet AC-T Instrumentation

AO Connection Dynamometric Handle 1,3 Nm

Manta Ray

Variable Awl

Chondro Pick

Chondro Pick Straight TIP Silicone Handle

Awl

Troch Nail Curved Awl

Buxton BioMedical

Awl 4-sided, linen-phen handle

Regatta

Straight Awl Variable

Boss Instruments

Shoulder Penetrating Awl, cvd, phenolic handle, 9 1/4"

Anax™ OCT Spinal System

3 catalogue numbers from OS0350, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Curved Cannulated AWL

3 catalogue numbers from 2810-01-005, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

IdentiTi

IdentiTi ALIF SA, Medial Awl, Angled, 40°

Falcon™ Anterior Cervical Plate

Falcon,awl

Perfix™ Spinal System

Catalogue number SI0210, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Orthopaedic Surgical Instruments

3 catalogue numbers from Cannulated awl, listed by Citieffe SRL, Italy, under Awl. 13 manufacturers in China are registered for this product code.

Orthomed

Shoulder Perc. AWL,8 1/2" Cvd.small

Adler Instrument Company

Penetrating AWL

Swanson

Awl w/ Pointed End

Innomed, Inc.

Polarstem Chili Pepper Starter Rasp Awl

Opteryx®

Cervical Awl Assembly, Radel, SST

Sonoma

Cervical Awl, Long

Dyna Locking Trochanteric Nail

8 catalogue numbers from NG9011, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Universal 2™ Total Wrist Implant System

Universal 2™ Total Wrist Implant System BONE AWL

Illico

Catalogue number 73711, listed by Alphatec Spine, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Awl

MODIFIED INSTRUMENT SELF CENTERING AWL 11mm

IdentiTi II

Alif SA Angled AWL, 35°

4WEB Medical

19 catalogue numbers from ASTS-SA-100004, listed by 4WEB Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Xcel

3.5MM X 24MM Xcel Anchor RC AWL

Antegra

Antegra AWL-Centering With Stop

Blackbird™ Spinal System

Blackbird,locking AWL

Angled Staple Punch

2 catalogue numbers from 17655, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

SMR Shoulder System

2 catalogue numbers from 9013.02.001, listed by Limacorporate, Italy, under Awl. 13 manufacturers in China are registered for this product code.

Reform MC Screw System

2 catalogue numbers from 59-RD-0400, listed by Precision Spine, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Endophix

5 catalogue numbers from MS-1529-2, listed by Suzhou Endophix Co., Ltd., China, under Awl. 13 manufacturers in China are registered for this product code.

Intervertebral Body Fusion Device

ALIF Cage Plate Universal Awl (10-1018 Handle)

Ortho Solutions Succession AFN System

Succession Trocar

Lospa IS Spinal System

MIS Spinal Needle

Dyna Locking IM Nail

5 catalogue numbers from IN1055, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Invictus

Targeting Needle, Diamond Tip Stylet

Anterior Lumbar Plate System

ALP Awl

Pass LP

Squared AWL Reamer Shaft

Trinica ALP Anterior Lumbar Plate System

2 catalogue numbers from 07.01046.001, listed by Highridge Medical, LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

DSS™ Awl

2 catalogue numbers from DAT50250, listed by Paradigm Spine GmbH, Germany, under Awl. 13 manufacturers in China are registered for this product code.

Skyhawk

Sleeved AWL

Scarlet AL-T Instrumentation

Straight Square AWL Light

Ucentum

Awl, cannulated, for screws Ø 10.0 mm, coupling A

Trigen

Fluted Curved Cannulated AWL

Straight Entry AWL

2 catalogue numbers from 21665, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Aesculap

OBWEGESER Awl (Mandibular), curved, 5 1/2" (140 mm)

Complete Cervical Stand Alone IBD

Awl - Spring Loaded - 12mm

Aprevo®

aprevo® Cervical Straight Awl

Polaris 4.75 Deformity System

4.75 TI AWL

RCS Anterior Buttress Plate System

22-9002

Meridian

Straight Awl Variable Sleeve

Securespan

Securespan AWL

Cylox ST

2 catalogue numbers from Awl straight, listed by Signus Medizintechnik Gmbh, Germany, under Awl. 13 manufacturers in China are registered for this product code.

Mega Plus MIS Spine System

Catalogue number 11170, listed by BK Meditech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Tecomet

Bone Awl, Diamond Point Tappered Custom, Green-Gray

Arsenal

Stopped AWL

Streamline® OCT Occipito-Cervico-Thoracic System

3 catalogue numbers from 26-AWL, listed by Pioneer Surgical Technology, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Zimmer® Cannulated Screw System

TROCAR, 1.25mm

Precice® Intramedullary Limb Lengthening System Instrument

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

Integra® Miltex®

Integra® Miltex® Obwegeser Zygomatic Arch Awl 9", Slight Curve, Wire suturing

Quattro®

3 catalogue numbers from CM-9200, listed by Cayenne Medical, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Paeon Anterior Cervical Plate System

2 catalogue numbers from CP02-0102, listed by Aegis Spine, United States, under Awl. 13 manufacturers in China are registered for this product code.

Blade® Anterior Cervical Plate System

Awl, Spring Loaded, 9mm

Novo Surgical

shoulder percussion awl, 8 1/2" (21.5 cm), large

Link Instruments – Chisel, Bone Curette, Raspatory, Rongeur

8 catalogue numbers from 64-4161/62, listed by Waldemar Link GmbH & Co. KG, Germany, under Awl. 13 manufacturers in China are registered for this product code.

Indy Standalone

Torque-Limiting Handle AO Male Connection

Tomcat Cervical Spinal System

Spcl,tomcat,awl,straight,long

CervAlign Anterior Cervical Plate System

Cervalign, Ø2.0MM AWL

Brickyard Alif

Torque-Limiting Handle, Small Hudson Connection

Perthes

Perthes, 16.0cm

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