Starter, Bone Screw

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Guangdong and Shanghai: 4 hold an FDA registration. 2 are contract manufacturers.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
B-ONE Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Jiangsu, contract manufacturer
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer

How Is HWD Classified?

Starter, Bone Screw is FDA product code HWD, 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 1 recall under this product code since 2011. None was by a company in China. The root cause the FDA records most often is Mixed-up of materials/components (1).

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

Starter, Bone Screw

Tibial Connecting Screw

Catalogue number 2141-45-001, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

General Instruments

AMP Bone Screwdriver, Twisted Hex, Offset

Starter, Bone Screw

Hintermann Series

Hintermann Series Quick Screw

Starter, Bone Screw

A/R Screw Trochar

Catalogue number SSI006171, listed by Zimmer, Inc., United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

S³SHOULDER Nail Plate Screw Sleeve

Catalogue number SNSS40, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Atn™lag Screw Sheath

Catalogue number 9030-03-101, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Anti-Rotation Screw Sleeve

Catalogue number 2112-01-503, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Screw Sheath

Catalogue number 1758, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Atn®lag Screw Cannulated TAP, Long

Catalogue number 9030-03-220, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Chsone Step Insertion CTR Sleeve Locking ASM

Catalogue number 939999726, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Starter, Bone Screw

Catalogue number 324.082, listed by Synthes (U.S.A.) LP, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

S³SHOULDER Nail Plate Lock Screw

S³SHOULDER Nail Plate Lock Screw: 1 catalogue number listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

KEY Screw Coupling ROD

Catalogue number 2142-04-033, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Distal Screw Trochar

2 catalogue numbers from 2112-01-402, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Starter, Bone Screw

Distractor Pins-Sterile 16MM Length

Starter, Bone Screw

Starter, Bone Screw

Femoral Notcher

Starter, Bone Screw

SET Screw HEX Driver

Catalogue number 2112-01-309, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

LAG Screw TAP

2 catalogue numbers from 2112-01-310, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Affixus®

Catalogue number 2112-01-320, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Atn™anti-Rotation Screw Sheath

Catalogue number 9030-04-101, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Atn™anti-Rotation Screw Trochar

Catalogue number 9030-04-104, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Atn™lag Screw Trochar

Catalogue number 9030-03-104, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Lag Screw Sheath

2 catalogue numbers from 2112-01-300, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Affixus®full Anatomy HEX Driver SET Screw

Catalogue number 2112-01-320, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Epix Lag Screw Trocar

Bone Screw Starter

Starter, Bone Screw

Matira Anterior Cervical System

Driver Shaft, T10 Split Tip

Starter, Bone Screw

NexGen Anterior Cervical Plate System

Screw Fixation Pin

Starter, Bone Screw

Atn®lag Screw Cannulated TAP

Catalogue number 9030-03-120, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Cannulated Cancellous TAP

Catalogue number 2461-14-627, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Countersink

5 catalogue numbers from 2312-20-206, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Solid Countersink

3 catalogue numbers from 8242-20-100, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Distal Screw

Catalogue number 2112-01-409, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

HemiCAP®

15mm Articular Comp 2.5mm x 4.5mm MTP

Starter, Bone Screw

General Instrument

Stab and Grab Screwdriver - Fixed Handle

Starter, Bone Screw

GSS™ and AnyPlus®

Set Screw Starter I-Handle

Starter, Bone Screw

Infinity

Poly Insert Attachment Screw

Starter, Bone Screw

Arsenal

Double Sided T27 SET Screw Inserter

Starter, Bone Screw

Centering Sleeve/Driver Stop

Catalogue number 2126-74-000, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Universal 2™ Total Wrist Implant System

Universal 2™ Total Wrist Implant System TRIAL SCREW 4/20MM

Starter, Bone Screw

Insert Captive HEX

2 catalogue numbers from 2312-11-001, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Easyout

Catalogue number 14620, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Lag Screw Trochar

2 catalogue numbers from 2112-01-301, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Power Dental U.S.A., Inc.

POWER PROSTHETIC KIT 1.2mm: Ankylos,Neobiotech, Dio, Hiossen/Ostem, Megagen.1.25mm: Astra, Dentium, Zimmer.1.3mm: Japan .etc.B/M: Branemark. Nobel Biocare.S/M: Straumann.

Starter, Bone Screw

Lag Screw Sleeve

Catalogue number 2112-01-302, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Starter, Bone Screw

Tunnel Notcher Bioabsorbable ACL Screw

Starter, Bone Screw

Universal2 Total Wrist Implant System

Trial Screw. 4.5MM. Cancellous. 20MML

Starter, Bone Screw

LAG Screw 3.2mm Sleeve

Catalogue number 2112-01-302, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Vantage

Catalogue number SPI-040950, listed by Exactech, Inc., United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Toetac

Hammertoe Implant Removal Tool

Starter, Bone Screw

LAG Screw Drill

Catalogue number 2112-01-303, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

IBS™

Forefoot Starter FOR Screw Stepped Profile

Starter, Bone Screw

Nido Pedicle Screw System

T-Handle, T30 Split Tip Cap Starter

Starter, Bone Screw

Made-To-Order

Inbone® Jack Screw

Starter, Bone Screw

Anti-Rotation Screw Removal Wrench

Catalogue number 9030-04-008, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Affixus

Catalogue number SSI004601, listed by Zimmer, Inc., United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Mariner MIS

Locking Set Screw Starter

Starter, Bone Screw

Endo-Model Knee System – Instruments

Bone file/rasp, manual, reusable - Endo Model Knee System

Starter, Bone Screw

ACE ™compression NUT

Catalogue number 9030-03-013, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Locking Screw DNP Anatomic

2 catalogue numbers from DNPALS, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Inbone

Poly Removal Tool, Retangular Housing

Starter, Bone Screw

Mobio™ Total Knee System

Headed Screw, 22mm

Starter, Bone Screw

Epix Distal Locking Trocar

Distal Locking Trocar

Starter, Bone Screw

Distal Screw Sheath

2 catalogue numbers from 2112-01-401, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Dakota Alif Plate System

Temporary Plate Fixation Pin

Starter, Bone Screw

Persona™

Catalogue number 42-5099-025-25, listed by Zimmer, Inc., United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Anti-Rotation Screw 3.2mm Sleeve

Catalogue number 2112-01-503, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Starter

Catalogue number 211-A30000, listed by Keri Medical, Switzerland, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Distal Screw Short HEX Driver

Catalogue number 2112-01-409, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

A/R Screw Sheath

Catalogue number SSI006170, listed by Zimmer, Inc., United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Link Instruments – Fixation Instruments

Orthopaedic instrument surgical connector - Gemini SL Total Knee System

Starter, Bone Screw

Screw Pick-UP

2 catalogue numbers from 2312-20-210, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Replacement Screws

Catalogue number 31-158000, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

A/R Screw 3.2mm Sleeve

Catalogue number SSI006172, listed by Zimmer, Inc., United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Slimplicity Anterior Cervical Plate System

Cervical Distraction Pin Caspar 12mm

Starter, Bone Screw

Hex Screwdriver

Catalogue number SSI005349, listed by Zimmer, Inc., United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

ACE ™LAG Screw Coupling ROD

Catalogue number 9030-03-010, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Femoral Connecting Screw

Catalogue number 2141-02-001, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Specials

Set Screw Starter, Tri-Flat

Starter, Bone Screw

CosmoLock Pedicle Screw System

Driver Shaft, T30 Split Tip Double End Cap Starter

Starter, Bone Screw

AMP-LTX

Bone Screwdriver, Stab n Grab Offset

Starter, Bone Screw

Kompressor™ Compression Screw System

SAMPLE, LEADING SCREW, MASTER, 18mm L - 26mm L

Starter, Bone Screw

Atoll

Catalogue number 16-40-0801, listed by Seaspine Orthopedics Corporation, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Affixus®jig Knob Large

Catalogue number 211201212, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Mariner

Set Screw Starter, T-Handle, Short

Starter, Bone Screw

Spark – Instruments

Orthopaedic instrument surgical connector - Gemini SL Total Knee System

Starter, Bone Screw

Atn®anti-Rotation Screw TAP

Catalogue number 9030-04-106, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Anti-Rotation Screw Sheath

2 catalogue numbers from 2112-01-501, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Tibiaxys®

The 40mm length screw for compression forceps is fixed on the bone through the extremity hole of the compression forceps with reference 219960ND to create a bone compression during the…

Starter, Bone Screw

Distal Tibia Handle SET Screw

2 catalogue numbers from 8163-01-007, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Anti-Rotation Screw Trochar

2 catalogue numbers from 2112-01-502, listed by Biomet Orthopedics, United States, under Starter, Bone Screw. 4 manufacturers in China are registered for this product code.

Starter, Bone Screw

Power Dental USA

POWER PROSTHETIC KIT ..1.2mm: Ankylos,Neobiotech, Dio, Hiossen/Ostem, Megagen...1.25mm: Astra, Dentium, Zimmer...1.3mm: Japan .etc...B/M: Branemark. Nobel Biocare...S/M: Straumann.

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