Bit, Surgical

Who Makes This Device Type in China?

3 of the 6 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Guangdong, Shanghai and Jiangsu, and 1 other province.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
Jiangxi Vision Plus Medical Technology Co., Ltd. Jiangxi
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer

How Is GFG Classified?

Bit, Surgical is FDA product code GFG, Class 1, 21 CFR 878.4820.

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 17 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Device Design (14) and Process control (1).

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

Locking Cannulated Blade Plate (LCB)

3.2MM Drill BIT Calibrated

Advance®

Advance® Quick Disconnect FOR 1/8" Drill BIT

Power Torque Instrumentation

3.5mm Hudson Tap - Single Lead

Medline

SMITH & NEPHEW SHRT, FOR 6MM HALF PIN 4

IBS™

2IN1 Drill Diam 2.2 LG32 MM AO NO Sterile Cannulated LG65 MM

Odyssey®

3 catalogue numbers from K0001022, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Medline Renewal

310.530 @DRL BIT FOR Maxillofacial Surge

Orthopediatrics Instrumentation

6.5mm/7.3mm Cannulated Screw retaining Sleeve, Short

Bit, Surgical

Drill Bit 2.0mm (5/64'') x 128.0mm, Non-Sterile

IntelliSense Drill Technology

IntelliSense Drill Bit Size 4.5mm x 160mm

MicroPort

5 catalogue numbers from 4820DR0300, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Superhawk

Superhawk Cannulated Drill 3.5mm

Conmed

Badger Cannulated Drill BIT, 7.5 MM X 229 MM (9")

Bit, Surgical

High Performance Stainless Steel Drill Bit

Pack Precision Allograft Cartilage Kit

CORING DRILL, 16mm

Made-To-Order

Perform Shoulder Depth Stop

Crossft

CrossFT Knotless 4.75 Drill Bit, Disposable

Multiloc

10.0MM Hollow Drill BIT FOR Multiloc Humeral Nail SYS-Ster

C-Reamer

C-Reamer, Cannulated 12.0 MM

Tornier Perform

Cannulated Drill/Reamer Driver With TIP

Conserve®

3 catalogue numbers from 48QF45DR, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Orthex External Fixation System

Orthex, Drill 3.8 x 200mm, Cannulated

Pack™

PACK 26mm Counterbore

Evolution®

Evolution® 3/8 IN Fully Fluted Drill W/ Quick Disconnect

Lineage

10 catalogue numbers from 8400FD03, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Orthex Drill Cannulated

Orthex Drill 3.5x160mm, Cannulated

Sentinel

Sentinel Cannulated Drill BIT, 10.5 X 229 MM (9")

Bit, Surgical

2.0MM Milling BIT With 2.35MM X 33.5MM Shaft-Sterile

Paradigm ClickLok

Paradigm ClickLok Drill Bit, 2.1 mm

SST Pro Tip

6 catalogue numbers from SST Pro Tip 0.8, listed by SeoulinMedicare Co., Ltd., under Bit, Surgical. 6 manufacturers in China are registered for this product code.

PediFlex Advanced ILC

AO 4.5 MM Drill

Mini-Revo

Mini-Revo Drill, 1.5 MM

Ortholoc

5 catalogue numbers from 5362000016, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Endo-Fuse

3 catalogue numbers from 500022, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Dart-Fire

9 catalogue numbers from DSDS0025S, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Salvation

Tapered Drill Bit

Acufex Trunav

Retrograde DRL 5.5MM

G-Force

Suture Anchor Pilot Drill Bit

TCP

11 catalogue numbers from 08-801, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Incompass Total Ankle System

Drill Tibial Corner

Infinity

Infinity 3.5 MM Spade TIP Guide PIN

OrthoPediatrics Cannulated Screw System

Cannulated Countersink - 5.5/6.0 Screws

Bit, Surgical

Burr, Side Cutting Drill

Darco

Drill Bit AO MFS System

Inbone

Drill, Anti- Rotation Notch

Evolve

EPS Drill Bit

Orthex Drill Solid

Orthex Drill 2.7x160mm, Solid, Centering Tip

Procotyl® Prime

3 catalogue numbers from P3FDB420, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

GraftMax™ Xactpin™

Graftmax Flex Xactpin Guide PIN

Y-Knot

Y-Knot Flex HIP Disposable Drill Pack FOR 1.3 MM Anchor

Ortholoc 3di

14 catalogue numbers from 588S50025, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Rayhack

4 catalogue numbers from 40100525, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Pediatric Nailing Platform Femur

PNP 3.2mm Drill Bit Short

Wave Calcaneal Fracture Plate

Cannulated HEX Driver

Pressft

PressFT Flex Drill Bit 2.6 mm, Hip

3p Hip System

3P 4.3mm Calibrated Cannulated Drill

Micronail II

Catalogue number 26948211, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Response Spine System

5.5/6.0 Pedicle Prep & Final Drive - Tray 1

Precision Allograft Cartilage Kit (Pack™)

PACK Coring Drill, 22mm

Acufex

Acufex Trunav Retrograde Drill 10.5 MM

Invision

Peg Drill

Wright

2 catalogue numbers from DSDS0027, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Bit, Surgical

3.8MM Three-Fluted Drill BIT QC/CALIBRATED/270MM-STERILE

Badger

Badger Cannulated Badger Drill BIT, 10.5 MM X 229 MM (9")

Response 5.5/6.0 Spine System

Power Tap, 7.0mm

Bit, Surgical

Neurairtome Wire Pass Drill, QTY 5

Omega

4.75MM Omega Drill

Xactpin

Xactpin Graft Passing Guide PIN, Sterile, 2.4 X 432 MM (.093 X 17 IN.)

Zimmer® Universal Power System

Radiolucent Drill 3.2 x 106 mm, Tri-Fluted, ZMH Shank

Charlotte

MUC Cannulated Screw, Head Drill

Revo

Thin Shaft Revo Driver

Phasor Drill

2 Flute Drill Bit.

PediFrag

2.0 MM Calibrated Drill BIT

Axiom®

10 catalogue numbers from 2271DR1000, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Microlink

Microlink, CMC Trapezium PIN

Ultrafix

Ultrafix Arthroscopic Drill, 2.4 MM

In2Bones

Reamer 2IN1 Diam 2.2 LG 11 MM AO Sterile Cannulated LG65 MM

GraftMax

Graftmax Indicator PIN

Bit, Surgical

Torque Driver Bit

Implant Partners™

Catalogue number E1000202WD, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Claw II

2 catalogue numbers from 402S50028, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

VersiTomic® ACL Flexible Reamer System Flexible Guide Pin

2 catalogue numbers from 234-108-020, listed by T.A.G Medical Products Agricultural Cooperative Association, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Stealth

Stealth Soft Bone Drill 3.0mm

Infinity

Tibial Corner Drill

Neofit

Drill Diam 2.0 MM Neofit

Profemur®

Catalogue number PRSEDRPK, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Locon-T

Screw Depth Guage

Gen II Cannulated Screws

Over the head Trephine

Bit, Surgical

Catalogue number 75.09.26, listed by Zimmer, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Thunderbolt

Thunderbolt Button Drill - Cannulated

Locking Proximal Femur System

2.5MM Drill BIT

Claw Charlotte

3 catalogue numbers from 40122000, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Poplok

Poplok Drill BIT, 2.8 MM

GII

Arthroscopic GII Drill Bit 2.4mm

Eleos™

Quick Disconnect FOR 1/8" Drill BIT

Cannulated Screw System

SQC Drill Bit

Ortholoc SPS

HEX Driver BIT

Bit, Surgical

Super/RC/GLS Arthroscopic Drill Bit 2.9mm

Neoview

Catalogue number P03 00051, listed by In2Bones SAS, France, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Ortholoc®

2 catalogue numbers from 16109020, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Anca-FIT™

2 catalogue numbers from PPR68016, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

MDI

2 catalogue numbers from 74001034, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

XO Button

XO Button Cannulated Drill BIT, 5 X 229 MM (9")

Locking Proximal Femur Plate System (LPF)

2.9 MM Cannulated Drill BIT

Locon

Catalogue number 79010008, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Distal Femoral Osteotomy System (Dfos)

2.5MM Calibrated Drill BIT

PediNail

2.9 MM Drill BIT

Argo Knotless

4.75/5.5 mm Argo Knotless Disposable Drill Bit

Ultrafix Micromite

Ultrafix Micromite Drill, 1.8 MM

OrthoPediatrics PediFoot Deformity Correction System

2.0mm Drill, Calibrated

Advantim®

Catalogue number 18610141, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

PNP Femur

PNP 3.2mm Drill Bit Short

E9000

E9000 BUR - Wire Pass, 1 X 38 MM

Pinn-ACL

Pinn-ACL Crosspin Drill BIT

Superpath®

Catalogue number 20071007, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

Micronail

Starter Drill

Neofuse

Diam 4.3 MM Drill NON Sterile 275 MM

913

Catalogue number APA00257, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

A.l.i.s.

Catalogue number APA04702, listed by Microport Orthopedics Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.

VersiTomic Low Profile 2.4mm Guide Pin, Sterile, Trocar

Catalogue number 234-111-024, listed by T.A.G Medical Products Agricultural Cooperative Association, under Bit, Surgical. 6 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