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.

LineSider

Catalogue number ASY-00177, listed by Highridge Medical, LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

Versanail®awl Stylus Large

Catalogue number 2810-01-125, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Panta®

The trocar awl is used to prepare the bone for drilling.

EnFix Instrument Kit – Complete

Catalogue number TET-KT-004, listed by Tetrous, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Anyplus Ll Spinal Fixation System

Anyplus II Navigation Awl Ø2.6

Optima™ ZS Spinal System

Catalogue number SZS1041, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

HPS Pedicle Awl Cannulated With K-Wire

Catalogue number HAT5026K, listed by Paradigm Spine GmbH, Germany, under Awl. 13 manufacturers in China are registered for this product code.

CosmoLock Pedicle Screw System

Awl, Thoracic Step

Tryptik 2 C-Plate Instrumentation

Catalogue number TRY-IN 12 00-N, listed by Spineart SA, Switzerland, under Awl. 13 manufacturers in China are registered for this product code.

Versaloop™ 2.5mm Reusable Awl

Catalogue number 210207, listed by T.A.G Medical Products Agricultural Cooperative Association, under Awl. 13 manufacturers in China are registered for this product code.

Gauthier Biomedical

Catalogue number 5161-00-5000 (G908179), listed by Gauthier Biomedical, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Profile

Profile AWL

Kheiron

Short square awl

Lospa Surgical Instruments

Start Awl

Cervical Awl

Catalogue number F008.0001, listed by Indius Medical Technologies PVT. Ltd., India, under Awl. 13 manufacturers in China are registered for this product code.

30 Degree Microfracture Pick

Catalogue number 909109, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

ABC2

ABC Bone AWL TO Open UP Cortical Bone

General Instruments

AWL X981000035 AWL Angled

Tapered Awl

Catalogue number F004.0067, listed by Indius Medical Technologies PVT. Ltd., India, under Awl. 13 manufacturers in China are registered for this product code.

Cannulated AWL 14MM

Catalogue number 471154, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Microfracture

Catalogue number SSI004564, listed by Zimmer, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Quasar-IF

Straight Awl, with Sleeve

Viper

Viper 2 System AWL, Cannulated

Quick Connect Awl

Quick Connect Aw

Reform Pedicle Screw System

Catalogue number 39-SP-0001, listed by Precision Spine, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

MSB/None

AWL 9870004 3.5 X 20MM

SureLOK Pedicle Screw System

SureLOK MIS Cannulated Awl

Scarlet® AL-T

Protected Angled Square Awl

Bone Cement Gouge, Outside Bevelled, 10MM X 310MM

Catalogue number 95-7180, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Ascent

Bone AWL, Ascent LE/Ascent Poct

Activ C

Activ C Bone AWL TO Open UP Cortic.bone

SMR Shoulder

Catalogue number 9013.55.001, listed by Limacorporate, Italy, under Awl. 13 manufacturers in China are registered for this product code.

OsteoBridge™

OsteoBridge IKA Knee Arthrodesis DIA 10.0 mm Manual Awl non-sterile

Inertia® Pedicle Screw System

Awl, 9mm

SynFix

LOW Profile U-Joint AWL FOR Synfix Mini-Open

Bone Awl

2 catalogue numbers from 000-A00900, listed by Keri Medical, Switzerland, under Awl. 13 manufacturers in China are registered for this product code.

Starfire™ Pedicle Screw System

Univ,cann,awl

Global Spinal Fixation System™

2 catalogue numbers from SGS1005, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Proview

Icon Bone AWL, 5.5MM

SureLOK Mini Posterior Cervical/Upper Thoracic System

Catalogue number 04-9044, listed by Precision Spine, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Bone Awl – Self Retracting

Catalogue number F003.0011, listed by Indius Medical Technologies PVT. Ltd., India, under Awl. 13 manufacturers in China are registered for this product code.

Anyplus II Spinal Fixation System

Anyplus II Awl

Titan Modular Shoulder System

Starter AWL 6MM

Evolve Proline

Proline Stem Starter Awl

Zimmer

3 catalogue numbers from CM-9200, listed by Provision, under Awl. 13 manufacturers in China are registered for this product code.

Awl

Catalogue number ASY-00177, listed by Integrity Implants, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

T-Handle

Catalogue number 22811, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Uniplate

UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM AWL 7mm

Versanail®curved Cannulated AWL

Catalogue number 2810-01-105, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

C-Curve

C-Curve Angled Squared AWL

Bawl Joint Awl

Catalogue number RO0014BJAZ, listed by Spineup Inc, United States, under Awl. 13 manufacturers in China are registered for this product code.

Oria Xena® Top Clip System

Xena,awl

Awl/Punch, 4.75/5.5mm Ventix® Link

Catalogue number 110025998, listed by Cayenne Medical, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Minature Bone Pick

Minature Bone Pick Microscopic Fracture Angled TIP Phenolic Handle

Vital™

Catalogue number 850M0059, listed by Biomet Spine, United States, under Awl. 13 manufacturers in China are registered for this product code.

Precice® Instruments

Orthopedic surgical instrument - Cannulated Awl

Centurion

Catalogue number 69-1001, listed by Orthofix US LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

Liska AWL

Liska AWL T-Handle

HammerTech

Catalogue number CD-HT-1000-S, listed by Fusion Orthopedics, LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

Illico FS

Catalogue number 74105, listed by Alphatec Spine, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Ennovate C

Ennovate C C1/C2 ALL-IN-ONE Guide Sleeve

Streamline TL Spinal Fixation System

Catalogue number 10-AWL, listed by Pioneer Surgical Technology, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Tornier Flex

Catalogue number MWF101, listed by Tornier Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Katalyst Bipolar Radial Head System

Catalogue number 226000, listed by Smith & Nephew, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

UCR

Catalogue number 91-0901, listed by Seaspine Orthopedics Corporation, United States, under Awl. 13 manufacturers in China are registered for this product code.

Holo

HOLO Awl

Peak

Peak Anterior Compression Plate System Starter AWL

Scarlet® AC-Ti

Guided Straight AWL

Curved Trocar Assy

2 catalogue numbers from 21668, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Awl, Quattro® Knotless Anchor 4.5/5.5mm

Catalogue number CM9100, listed by Cayenne Medical, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Arcadius XP C

Arcadius XP C Ball Joint AWL

Symphony

SYMPHONY OCT SYSTEM AWL 2.0mm

Awl

starter broach

Punch

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

Diplomat MIS

Catalogue number Awl cannulated, listed by Signus Medizintechnik Gmbh, Germany, under Awl. 13 manufacturers in China are registered for this product code.

PathFinder NXT Minimally Invasive Pedicle Screw System

Cannulated T-Handle Bone Awl III

Aspiron™ S ACP System

Catalogue number FC7210, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Starter Awl Tapered

Catalogue number 75120019, listed by implantcast GmbH, Germany, under Awl. 13 manufacturers in China are registered for this product code.

ZMS®

2 catalogue numbers from 2246-62, listed by Zimmer, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Pointed AWL

Catalogue number 1124-00-000, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

DSS™ Pedicle Awl Cannulated

Catalogue number DAT50265, listed by Paradigm Spine GmbH, Germany, under Awl. 13 manufacturers in China are registered for this product code.

IM Nail Awl

Catalogue number 8900-20, listed by A.M. Surgical, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Imhs

Asian Imhs 25 DEG Cannulated AWL

Mountaineer

Mountaineer OCT Spinal System AWL

Conklusion

Conklusion: 1 catalogue number listed by Signus Medizintechnik Gmbh, Germany, under Awl. 13 manufacturers in China are registered for this product code.

Awl With Stop

Catalogue number RO0016ASZZ, listed by Spineup Inc, United States, under Awl. 13 manufacturers in China are registered for this product code.

Vitality®

2 catalogue numbers from 07.02076.001, listed by Zimmer Spine, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Moss

Moss Miami Magnum Spine System Pedicle AWL 6.35

Daniel Nasal AWL

Catalogue number 467-414, listed by Sontec Instruments, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Gallery Laminoplasty Fixation System

Gallery Standard AWL 2.0MM DIA

Neon3

Catalogue number CS 3920-01, listed by Ulrich Gmbh & Co. KG, Germany, under Awl. 13 manufacturers in China are registered for this product code.

Bone Pick

Catalogue number 320-00-013, listed by Trilliant Surgical LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

Angled Awl

Catalogue number RO0013AAZZ, listed by Spineup Inc, United States, under Awl. 13 manufacturers in China are registered for this product code.

CorticaLINK

Catalogue number 80-4510, listed by Linkspine, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)

Threaded Awl (Metal Handle)

Coda™ Anterior Cervical Plate System

Awl Sleeve

Stryker

2 catalogue numbers from 3910-947-200, listed by Provision, under Awl. 13 manufacturers in China are registered for this product code.

Katalyst™ Bipolar Radial Head System

Katalyst™ Bipolar Radial Head System STARTER AWL

Mariner

3 catalogue numbers from 90-1101, listed by Seaspine Orthopedics Corporation, United States, under Awl. 13 manufacturers in China are registered for this product code.

S³SHOULDER Nail Plate AWL

S³SHOULDER Nail Plate AWL: 1 catalogue number listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Silicone PIP

Catalogue number 17-0871, listed by Stryker GmbH, Switzerland, under Awl. 13 manufacturers in China are registered for this product code.

Arcadius XP L

Arcadiusxp L Hexalobe Ball Joint AWL

Calibrate

LTX Adjustable AWL

Pass MIS

Pointed K-Wire

Tornier Latitude

Crimping Clamp - AWL Adapter

AO AWL Shaft

Catalogue number 14-401414, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Sterile Spine Pedicle Screw System

Awl, Palm, Trocar

PSS System

Pedicle Awl

Ascension MCP Joint Replacement

AWL. Starter

Curved Entry Awl

2 catalogue numbers from ODIT118, listed by Orthopedic Designs North America, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Vault C Acdf System

2 catalogue numbers from 37-HP-0020, listed by Precision Spine, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Affixus®

2 catalogue numbers from 211300000, listed by Zimmer, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

SynFix

Synfix Evolution U-Joint AWL Assembly

Ventix®

2 catalogue numbers from 110025998, listed by Cayenne Medical, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Orthros

Catalogue number CP-124-17, listed by Camber Spine Technologies, United States, under Awl. 13 manufacturers in China are registered for this product code.

A-Space Sibd

Flexible Bone AWL

Butrex Buttress Plating System

Assembly, Bone Awl

Oxford Unicompartmental Knee Phase 3INTRAMEDULLARY AWL

Catalogue number 32-420540, listed by Biomet UK Ltd., United Kingdom, under Awl. 13 manufacturers in China are registered for this product code.

Golden Isles Pedicle Screw System

2 catalogue numbers from C50-2000-007, listed by Intelivation Technologies, LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

Union Cervical Plate System

Awl with Stop, with strike cap

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