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.

Scarlet ® AC-T

Beveled Straight AWL

Endoskeleton™ TCS Interbody System

AWL 5210-1066 TCS 45 DEG ART Curv Rtrct

Symmetry Surgical

Symmetry® Awl; Shoulder Penetrating; Phenolic Handle; 9 1/4 in

12.2MM Curved Cannulated AWL

Catalogue number 14-442003, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Panama™

Catalogue number Panama™, listed by Flospine LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

Altivo™ Anterior Cervical Fixation System

Awl, Freehand

Trauma Fixation Systems

2 catalogue numbers from 14-442004, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

EnFix Instrument Kit – TAC

Catalogue number TET-KT-006, listed by Tetrous, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

HPS Awl With Blunt Tip

2 catalogue numbers from HAT50252, listed by Paradigm Spine GmbH, Germany, under Awl. 13 manufacturers in China are registered for this product code.

Awl 9mm & 10mm

Used to insert the screw of the WasherCap™ Fixation System.

Precice® Trauma Nail System

Nail Measuring Gauge, 80cm

Sahara™ Stabilization System

Fixed Awl, Size 20 mm

Shoreline

Angled Awl, 12mm

Splitting Chisel, 10MM X 310MM

Catalogue number 95-7545, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Integra® Jarit®

Integra® Jarit® Obwegeser Zygomatic Arch Awl 9", Slight Curve, Wire Suturing

Lat-Fuse™ Lateral Plate System

2 catalogue numbers from 38-DRILL, listed by Pioneer Surgical Technology, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

TTC Fusion Nailawl Trochar

Catalogue number 8207-02-000, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Osteotec Silicone Finger – Starter Awl

The standard bone awl is required for making the first mark.

3s Hemi

3S Hemi, Non-Sterile, Awl

AMP

LLIF AMP, Adjustable Awl

Spira-C Integrated

Awl, Cervical

Cutting Awl – 5.5mm

Catalogue number TET-INS-012, listed by Tetrous, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Perfix Deformity Instrument System

2 catalogue numbers from SNDS1001, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Awl

Bone Perforator, Pencil Tip

Awl

10 catalogue numbers from 70.08.89, listed by Zimmer, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Surgical Instruments

PIP Alignment AWL

Inertia® MIS Pedicle Screw System

Awl Tap, SQR, 5.5mm-4.5mm

GluOn-IF

2 catalogue numbers from GS136-0110, listed by GS Medical Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

The Tether™

Anchor Inserter Standard AWL

Silicone MCP

Catalogue number 17-0835, listed by Stryker GmbH, Switzerland, under Awl. 13 manufacturers in China are registered for this product code.

Parcus Instrumentation

4.8mm SLiK Awl

Made-To-Order

K1 Glenoid Awl

GSO ACP1 Spinal System

Catalogue number 509722, listed by Unified Spine, LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

Endoskeleton® TAS

Bone Awl, U-Joint Assembly

Pisces-SA

Self-Guided Awl, Straight

Tornier Humeral Nail

Catalogue number 9020010, listed by Tornier Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Aspect Anterior Cervical Plate System

Sleeve, Bone AWL, Spring-Loaded

Aspida

Adjustable ASPIDA Awl Guide

Awl 7mm & 8mm

Used to insert the screw of the WasherCap™ Fixation System.

Awl – Non-Cutting

Catalogue number TET-INS-011, listed by Tetrous, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Stabolt

Catalogue number A14010200, listed by Medicrea International, France, under Awl. 13 manufacturers in China are registered for this product code.

Easyspine

3 catalogue numbers from ES9032R, listed by Ldr Spine USA, United States, under Awl. 13 manufacturers in China are registered for this product code.

Novocart

Novocart 3D Drill

Cosy

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

SynFix-LR

Straight AWL Synfix-LR

Trestle Luxe

Awl, For Drill Guide

Awl

Catalogue number ODIF02, listed by Orthopedic Designs North America, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Kaneda SR

Kaneda SR Anterior System Angled AWL (Modular)

Tapered Awl/Punch, 4.75/5.5mm Ventix™ Link

Catalogue number 110025999, listed by Cayenne Medical, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Bowti

Bowti Anterior Buttress Staple AWL

Small Staple Punch

2 catalogue numbers from 17654, listed by Biopro, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

AMP II

Lateral Plating Awl, Adjustable

Cslp

AWL FOR Temporary Fixation Pins-Cslp

Innoverse Spinal System

Catalogue number NP0010, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

The Tether Vertebral Body Tethering System

Anchor Inserter Standard Awl

Hexanium® Acif

Short Angulated Bone Awl

Salvo® Spine System

Awl, Cannulated

Isola

Isola Spine System AWL 90 Degrees

Spider Cervical Plating System

Assembly, Self-Centering Bone AWL

Streamline MIS Spinal Fixation System

Streamline MIS, Cannulated Bone Awl

Streamline OCT

Streamline OCT Awl, 6mm, Grey Handle

GSO PCT Spinal System

Bone Awl Assembly

Novo Surgical Inc.

kuntscher diamond pointed awl, w/ handle, 11" (28.0 cm), 10.0 mm femur awl

DuaFit®

Duafit Canal Shaper Proximal P1

Pilling

5 catalogue numbers from IPN020014, listed by Teleflex Medical LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

NexGen Anterior Cervical Plate System

Variable Awl - Large Handle

CPT®

3 catalogue numbers from 8334-65-04, listed by Zimmer, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Summit

Summit SI OCT Spinal Fixation System AWL

Solanas

Thoracic Screw Bone AWL

Romeo 2 MIS

Trocar needle

Aida® Awl Bowed

Catalogue number 80071024, listed by implantcast GmbH, Germany, under Awl. 13 manufacturers in China are registered for this product code.

Specials

Cannulated Awl with Fixed Handle, 20 mm

Ascend

Catalogue number SH0713, listed by Tornier Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Contact® ALP Anterior Lumbar Plate System

2 catalogue numbers from 25-AWL, listed by Pioneer Surgical Technology, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Ambler Surgical

Kuntscher femur awl, 11'', curved, 10.0mm diameter, diamond pointed

GSS™ and AnyPlus®

Catalogue number GS110-0216, listed by GS Medical Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Cervalign

Cervalign, Ø2.0MM AWL

Mega Plus Spine System

Catalogue number 51640-08, listed by BK Meditech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Antegra-T

Antegra-T AWL-Extra Long

Sierra

Catalogue number 95-0110, listed by Seaspine Orthopedics Corporation, United States, under Awl. 13 manufacturers in China are registered for this product code.

Symmetry

Symmetry® Awl; Obwegeser Maxillary; 6 1/2 in

TYPHOON™Facet Screw Fixation System

Typhoon,mi,awl,solid

Proximity

Proximity Awl, 12mm

PAC Plate® Anterior Cervical Plate System

Cervical Bone AWL Modular

Awl

9 catalogue numbers from 802713, listed by George Tiemann & Co., United States, under Awl. 13 manufacturers in China are registered for this product code.

DSS™ Pedicle Awl Cannulated With K-Wire

Catalogue number DAT5026K, listed by Paradigm Spine GmbH, Germany, under Awl. 13 manufacturers in China are registered for this product code.

Firebird SFS

Bone AWL, Cannulated

Bone Pick

Bone Pick Microscopic Fracture Angled TIP Phenolic Handle

M/DN®

8 catalogue numbers from 2255-12-50, listed by Zimmer, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

AWL

2 catalogue numbers from 2112-01-100, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Kmedic

Shoulder Penetrating AWL,9 1/4" Curved Phenolic

Anmuth Medical International

Single Slot Screwdriver w/ Phenolic Handle, 6.75"

UniSpace® Stand-Alone C Cage

6 catalogue numbers from AU0080, listed by CG MedTech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.

Medtronic Resuable Instruments

AWL EX0616054 Strght Flexible-Trocar TIP

Custom

Squared AWL Reamer With Soft Handle

Dakota Acdf System

2 catalogue numbers from 71-IN-0010, listed by Precision Spine, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Metal Hemi

2 catalogue numbers from 70011002, listed by Wright Medical Technology, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

APR®

2 catalogue numbers from 9301-01-003, listed by Zimmer, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Endoskeleton® TCS

Retractable Straight Awl, Straight

MaxAn Anterior Cervical Plate System

2 catalogue numbers from 14-521060, listed by Highridge Medical, LLC, United States, under Awl. 13 manufacturers in China are registered for this product code.

Arcadius XP L

Arcadius XP L U-Joint Bone AWL

Genie RCR Instruments

Ø5.25 Reusable AWL(Healmax)

Slimplicity Anterior Cervical Plate System

2 catalogue numbers from 08-9004, listed by Precision Spine, Inc., United States, under Awl. 13 manufacturers in China are registered for this product code.

Distal Targeting AWL

2 catalogue numbers from 14-442004, listed by Biomet Orthopedics, United States, under Awl. 13 manufacturers in China are registered for this product code.

Fixed Angle Awl

Catalogue number RO0012FAAZ, listed by Spineup Inc, United States, under Awl. 13 manufacturers in China are registered for this product code.

Malibu

Threaded Awl 5.0mm (For 5.5mm Screw)

Accufit Lateral Plate System

2 Hole DTS Awl - 25mm

Awl

AWL 2151130 Straight AWL - Bevel TIP

Omnia Medical TiBrid SA

U-JOINT AWL SHORTENED TIP (special)

Sklar®

Censitrac Ready Diamond Point AWL Femur 10MM

Expedium

Expedium Anterior Spine System Guide Block AWL, Modular

Smith and Nephew

Catalogue number 72202621, listed by Provision, under Awl. 13 manufacturers in China are registered for this product code.

Aegis

Aegis Anterior Lumbar Plate AWL, Variable

Atoll

Catalogue number 16-40-0100, listed by Seaspine Orthopedics Corporation, United States, under Awl. 13 manufacturers in China are registered for this product code.

S4 Cervical

S4C Bone AWL F/Smooth Shank Screw

Shoreline ACS

Angled Springloaded Awl, 10mm

SFS

Bone AWL SFS Hook System

Spira®-A Integrated

SPIRA®-A Integrated, Angled Awl

Matira Anterior Cervical System

AWL, 10MM Spring Loaded

KICo AWL

MO-AWL-0650-B Awl Cutting 5.5mm

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