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.

Quick Connect Awl, With Stop

Quick Connect Aw, With Stop

Segmental Plating System

SPS Straight Awl, 12 mm

Elatus Lumbar Plate System

Catalogue number LP01-0101, listed by Aegis Spine, United States, under Awl. 13 manufacturers in China are registered for this product code.

Anchor Instrumentation

Catalogue number 905588, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Interspinous Plate System

Tissue Awl

Awl

Cannulated AWL With T-Handle

Instrument

Starter AWL Triathlon Revision Instruments

Trinica/Trinica Select Anterior Cervical Plate System

Cervical Plate, Awl, Assembly

Impix-Alif S/A

45° Angulated Square AWL

Anax™ OCT System

Catalogue number OS0350, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Natural Nail®

5 catalogue numbers from 00-2490-010-00, listed by Zimmer, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Reform Poct System

Catalogue number 55-IN-0010, listed by Precision Spine, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Ascot

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

Pillar SA Ti

Sleeved Straight AWL

Anax™ 5.5 Spinal System

3 catalogue numbers from SF0340, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Oxford Knee SystemI/M AWL

Catalogue number 32-423226, listed by Biomet UK Ltd., United Kingdom, under Awl. 13 manufacturers in China are registered for this product code.

Tensor

3 catalogue numbers from 3230, listed by Provision, under Awl. 13 manufacturers in China are registered for this product code.

Vital MIS Spinal Fixation System

Vital™ MIS Cannulated Awl

Toe Punch

Catalogue number 15112, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Reform TI Pedicle Screw System

Cannulated Bone Awl

Angled Awl, With Stop

Angled Awl With Stop

Tryptik CC Instrumentation

Catalogue number TRY-IN 00 03-N, listed by Spineart SA, Switzerland, under Awl. 13 manufacturers in China are registered for this product code.

PediFlex

2 catalogue numbers from 01-1001-0001, listed by Orthopediatrics, Corp, United States, under Awl. 13 manufacturers in China are registered for this product code.

AlphaVent

4.75MM Alphavent Punch-TAP

Splitting Chisel, 5MM

Catalogue number 95-7546, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Awl Trocar

Catalogue number 1F0I210A, listed by I.T.S. Gmbh, Austria, under Awl. 13 manufacturers in China are registered for this product code.

Slim-LOC

Slim-LOC Anterior Cervical Plate System AWL Assembly

Integra®

Integra® Silicone PIP Starter Awl The Starter Awl is used to penetrate the articular surface and expose the canal of the metacarpal and phalangeal bone.

Xlarge Anchor Awl 8mm

Catalogue number IB-IA-8590, listed by Arteriocyte Medical Systems, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation System

AWL With Stop (8MM)

Isto Disposable Awl 5.5/6.0 Anchor

Disposable Awl 5.5/6.0 Anchor

Aranax Anterior Cervical Plating System

Self-Centering Bone AWL

0 Degree Microfracture Pick

Catalogue number 909106, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Contact ALP

Special Bone AWL, 14" OAL, 0.145" TIP

Link Embrace Shoulder System – Instruments

Surgical implant template, reusable - LINK Embrace Shoulder System

Zuma-C

Awl for Freehand Guide

SpineTune TL

2 catalogue numbers from ST9001R, listed by Ldr Spine USA, United States, under Awl. 13 manufacturers in China are registered for this product code.

Awl, Quattro® Suture Anchor 5.5/6.5mm

Catalogue number CM9200, listed by Cayenne Medical, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Micronail

Catalogue number 26949471, listed by Wright Medical Technology, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Awl

Catalogue number RO0010AZZZ, listed by Spineup Inc, United States, under Awl. 13 manufacturers in China are registered for this product code.

Skyline

Skyline Anterior Cervical Plate System Constrained - AWL - Shaft

Awl

Probing AWL Straight

Medium Anchor Awl 6mm

Catalogue number IB-IA-6570, listed by Arteriocyte Medical Systems, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Titan™

Titan™ Total Shoulder System Starter Awl 6mm The Starter Awl is used to penetrate the articular surface and expose the canal.

Apelo® / Apelo® MIS

Catalogue number 2006-15-0000, listed by Atlas Spine Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Discovery Elbow

Catalogue number 414801, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

TwinLoop

AWL, 3.5MM Twin Loop

Endoskeleton™ TL Interbody System

AWL 7200-1109 TLH Retractable Angled

Iconix

2.3MM Iconix Reusable AWL

Aim™cannulated AWL

Catalogue number 1122-00-000, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Streamline TL Spinal Fixation System

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

MSB Reusable Instruments

AWL 5210-1022 TCS Straight Retractable

Isto Disposable Awl 6.5/7.0 Anchor

Disposable Awl 6.5/7.0 Anchor

Zodiac

Stopped Bone AWL

Large Anchor Awl 7mm

Catalogue number IB-IA-7580, listed by Arteriocyte Medical Systems, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

InViZia Anterior Cervical Plate System

Catalogue number 07.01585.001, listed by Highridge Medical, LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

Zuma-L

Zuma-L Awl

10 Degree Microfracture Pick

Catalogue number 909104, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Awl

Curved Awl

Excella II®

Bone Awl, w/ Impact Cap, .146 Tip, Al, Silicone, SST

Aesculap

Arcadiusxp L Ball Drill

GAP Endo-EXO Medullary System

GAP Bone AWL

Medicon

Obwegeser awl f zygomatic arch 23.5cm

Biopro Curved Trochar

Curved Trochar Impactor

Isto Disposable Awl 8.5/9.0 Anchor

Disposable Awl 8.5/9.0 Anchor

Peterson Bone Pick

Peterson Bone Pick Microscopic Fracture Angled TIP Phenolic Handle

Slimfuse Anterior Cervical Plate System

Fixed Handled Bone AWL

Cutting Awl – 4.5mm

Catalogue number TET-INS-013, listed by Tetrous, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Awl

Catalogue number 405-697, listed by Pioneer Surgical Technology, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

ACE

AWL Mandibular #18 5-3/4" 14.5CM

AMP-LTX

Awl, Adjustable

Cassiopeia ACP

Cervical Awl, for Drill Guide

Zuma

Catalogue number 95-5170, listed by Seaspine Orthopedics Corporation, United States, under Awl. 13 manufacturers in China are registered for this product code.

Chisel

Catalogue number 15112, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Bawl Joint Awl, With Stop

Catalogue number RO0020BJAS, listed by Spineup Inc, United States, under Awl. 13 manufacturers in China are registered for this product code.

Insignia

Awl Constraining Sleeve

Baguera C Instrumentation

Articulated Cervical distractor

Struxxure™ Anterior Cervical Plate and Screws

Struxxure, Awl, Spring Loaded, Pear Handle

AT 2.9 Punch – M

AT 2.9 Punch – M: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Awl. 13 manufacturers in China are registered for this product code.

AWL Stylus

Catalogue number 2810-01-025, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Large Staple Punch

2 catalogue numbers from 17653, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Isto Disposable Awl 7.5/8.0 Anchor

Disposable Awl 7.5/8.0 Anchor

Indy

Torque-Limiting Handle, Small Hudson Connection

Avitus Orthopaedics

Catalogue number PC-100, listed by Provision, under Awl. 13 manufacturers in China are registered for this product code.

Firebird NXG

Catalogue number 36-1001, listed by Orthofix US LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

Fanelli PCL Tunnel AWL

Catalogue number 909798, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

AnyPlus®

2 catalogue numbers from GS114-2120, listed by GS Medical Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Nakoma

Bone Awl Instrument

Vu a-POD Prime NanoMetalene

Angled Awl, Beveled

AlphaVent, Omega

3.9MM Omega AND 4.75MM Alphavent AWL

Optima™ Spinal System

2 catalogue numbers from SI0210, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Small Anchor Awl 5mm

Catalogue number IB-IA-5560, listed by Arteriocyte Medical Systems, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Surgical Instrument

4 catalogue numbers from 111-473, listed by Jeil Medical Corporation, South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Cordant

Spring Loaded Awl

Pass ANT

Curved Square AWL

Virage OCT Spinal Fixation System

Catalogue number 07.01752.001, listed by Highridge Medical, LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

Awl, Curved, Cannulated

Catalogue number 1F0I205A, listed by I.T.S. Gmbh, Austria, under Awl. 13 manufacturers in China are registered for this product code.

Pass OCT

Occipital AWL

Tether

Fixed Self-Centering Awl 10mm

Diplomat

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

20 Degree Microfracture Pick

Catalogue number 909102, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Romeo Posterior Osteosynthesis System

Square AWL Bayoneted

Eagle Swift

EAGLE/SWIFT ANTERIOR CERVICAL PLATE SYSTEM AWL 10mm

Balboa

Awl, 20mm

Starter AWL

Starter AWL: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Awl. 13 manufacturers in China are registered for this product code.

Reverse Handle AWL

Catalogue number 470342, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Endo-Model Knee System – Instruments

Bone awl, reusable - Endo Model Knee System

Coral

Bone Awl, 4.0mm Screw

Curved Trocar Cannula

Catalogue number 21391, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Fanelli™ PCL

Catalogue number 909798, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Quick Connect Ball Joint Awl With Stop

Catalogue number RO0038QBAS, listed by Spineup Inc, United States, under Awl. 13 manufacturers in China are registered for this product code.

Biozip

AWL, 6.5 MM Biozip Anchor

NorthStar

Catalogue number PC2-100001, listed by Seaspine Orthopedics Corporation, United States, under Awl. 13 manufacturers in China are registered for this product code.

Diamond Point- Tibia AWL

Catalogue number 470320, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Moss

Moss Miami Spine System Pedicle AWL

Romeo 2 Instrumentation

Trocar 3 IN 1 - T-Handle

Universal2 Total Wrist Implant System

Catalogue number 268220, listed by Smith & Nephew, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Admiral

Self Guiding Awl, 10mm, Variable

MEGA5.5 Spine System

Catalogue number 81640, listed by BK Meditech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

GSO GS1 Spinal System

2 catalogue numbers from 508246, listed by Unified Spine, LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

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