Template

Which Manufacturers in China Make This?

11 of the 21 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Jiangsu, Shanghai and Fujian, and 4 other provinces.

Arthrex (Shanghai) Co., Ltd. Shanghai
B-ONE Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
Beijing Fule Science & Technology Development Co., Ltd. Beijing
Canwell Medical Co., Ltd. Zhejiang, contract manufacturer
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Jiangsu, contract manufacturer
Changzhou Biomet Medical Devices Co., Ltd. Jiangsu, contract manufacturer
Double Medical Technology Inc. Fujian, contract manufacturer
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
Guangzhou Clean Medical Products Manufacturing Corp Guangdong, contract manufacturer
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Jiangsu
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Suzhou AND Science & Technology Development Corp. Jiangsu, contract manufacturer
Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
Sanbor Medical Xiamen, Inc. Fujian, contract manufacturer
Suzhou Ahno Medical Devices Co., Ltd. Jiangsu, contract manufacturer
Suzhou Elite Precision Machinery Co., Ltd. Jiangsu, contract manufacturer
Xinhua Healthcare Industry Co., Limited Shandong, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code HWT?

Template is FDA product code HWT, Class 1, 21 CFR 888.4800.

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 85 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 (47), Process control (9) and Employee error (5).

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

Inhance

Inhance Make TO Order PIN Drill Guide - Large

Anatomic Trial Sizer With Stop 20×12, H11mm

Catalogue number RO0397AG1120X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Recap® Femoral Head

11 catalogue numbers from 31-500941, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer With Stop 20×14, H07mm

Catalogue number RO0403AH0720X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Duraloc

Duraloc Option Trial LPW 62 / 64 OR 66 X 28

FX RPP Lateral Prov Neck L 15-21

Catalogue number SSI007196, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

All Poly Tibia Trial Shim

3 catalogue numbers from 122-18-0325, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

HUM TR LT +0MM EXT 40 +3MM RET

Catalogue number SSI007802, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

53x28mm Locking Polarcup Trial

Catalogue number 35130034, listed by Enztec Limited, New Zealand, under Template. 21 manufacturers in China are registered for this product code.

G7 Snap-In Neutral Prov Size 36 J

Catalogue number SSI008248, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

TriVerse X-Ray Digital Template, Tibial Tray

Catalogue number 02-039-95-0095, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

140 DEG Drill GDE

Catalogue number SSI006986, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

14x16mm, 6mmx6° Kodiak Cervical Trial

Catalogue number 07-0037J, listed by Met 1 Technologies, LLC, United States, under Template. 21 manufacturers in China are registered for this product code.

OSS RS ROT Hinged Knee Provisional 22MM Bearing Extended Post

Catalogue number SSI008555, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Maxrom Ring-LOC +5 Provisional

8 catalogue numbers from 31-105958, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Redemption

X-Ray Template - Assembly

OSS RS ROT Hinged Knee Provisional 12MM Bearing Extended Post

Catalogue number SSI008550, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Titan Reverse Shoulder System

Humeral Body Trial W/ Definitive LRG MOD

Medtronic Resuable Instruments

ROD Template X0716033 WT Expsd Hndl 70MM

NorthStar

Catalogue number PC2-200003, listed by Seaspine Orthopedics Corporation, United States, under Template. 21 manufacturers in China are registered for this product code.

Femoral Trial PS Insert

7 catalogue numbers from 122-10-0337, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer 18×14, H05mm

Catalogue number RO1271AF0518X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

14x16mm, 11mmx6° Kodiak Cervical Trial

Catalogue number 07-0042J, listed by Met 1 Technologies, LLC, United States, under Template. 21 manufacturers in China are registered for this product code.

Multi System

Trial Handle, Cotton, 8mm

H-Graft Interspinous Allograft

20mm Trial Block

Mallory/Head(R) Standard

14 catalogue numbers from 104365, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Impix-Tlif

TRIAL FOR IMPIX-TLIF 13mm - 6°

Distal Tibial A-Plate Trials

Catalogue number FIS 654, listed by Flower Orthopedics Corporation, United States, under Template. 21 manufacturers in China are registered for this product code.

2.2MM Hitch(TM) Drill

Catalogue number 905950, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Specialist P.F.C. Sigma

Specialist 2 Chamfer Guide With Removable Handle SZ 6 P.F.C. Sigma

Trial CUP D64 Mm

2 catalogue numbers from H0030155409, listed by HPF SRL, under Template. 21 manufacturers in China are registered for this product code.

Long Provisional Head/Neck

2 catalogue numbers from 31-173135, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Trial CUP D41 Mm

2 catalogue numbers from 9055.28.441, listed by HPF SRL, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer 20×14, H04mm

Catalogue number RO1300AH0420X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Mold

Mold, PRS, 14-Hole, Straight

Anatomic Trial Sizer 18×12, H07mm

Catalogue number RO1263AE0718X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

G7 Snap-In Hi-Wall Prov Size 28 B

Catalogue number SSI008252, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

MTP Trial

TMC MTP Trial, 14MM

DVR® Anatomic Narrow Short Left Trial

Catalogue number 2312-12-110, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Flap Marking Template

Patient specific, 3D printed, single use surgical flap marking template based a patient’s baseline status and treatment plan. RX only, non-diagnostic.

TCP

Catalogue number 08-901, listed by Wright Medical Technology, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Vikos® Allograft System

Assembled Straight Trial, Size 10x24x13 mm 0°

World Knee Tibial Monotrial – UC

9 catalogue numbers from 122-18-0587, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Aria Stem Size 6 Template

Catalogue number 111-201-606, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Gladstone Alif Trial Cage

Catalogue number W32-04-0205, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Juliet ® LL

Lateral Rasp Trial 21MM H12

Oxford® Partial Knee System

2 catalogue numbers from 512211150, listed by Biomet UK Ltd., United Kingdom, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer 18×14, H10mm

Catalogue number RO1276AF1018X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Endoskeleton® TL

Trial, 7 Deg Lordotic, Straight, 18mm x 12mm

Coronoid Plate Right Trial

Catalogue number 2312-18-500, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Biomet® Tibial Locking Trial

9 catalogue numbers from 32-482116, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Mobio™ Total Knee System

EM Tibial Alignment Guide, Non-Spiked Uprod, Standard

Anatomic Trial Sizer 18×14, H04mm

Catalogue number RO1270AF0418X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

TriVerse AS Tibia Insert Trial, 63×16

Catalogue number 122-22-6636, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

TriVerse X-Ray Digital Template, Tibial 40 MM Keel

9 catalogue numbers from 02-039-95-3491, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

OrthoMedFlex

Trial Liner 20° 32/60-70 (E)

Graftmaster

Graftmaster III Suture Vise With Tensiometer

Distal Radius Plate Trials, 2.3mm Volar, Narrow

Catalogue number FIM 510, listed by Flower Orthopedics Corporation, United States, under Template. 21 manufacturers in China are registered for this product code.

Anax™ OCT System

Catalogue number OS0240, listed by CG MedTech Co., Ltd., South Korea, under Template. 21 manufacturers in China are registered for this product code.

Microplasty® Vanguard® Elite Instruments

Catalogue number 32-484030, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Oxford Femoral Drill Guide IM Adaptor

Catalogue number 32-423400, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Anatomical Shoulder™

8 catalogue numbers from 01.04700.160, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

DVR® Anatomic Wide Head Left Trial

Catalogue number 2312-12-112, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Quickset

Quickset Acetabular Grater Positioner

Level ONE, Sterile

Forming Device FOR Orbital Implants

OSS(TM) RS Tibial Augment

4 catalogue numbers from RD122162, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Femoral Trial CR Insert

7 catalogue numbers from 122-10-0490, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

14x16mm, 7mmx6° Kodiak Cervical Trial

Catalogue number 07-0038J, listed by Met 1 Technologies, LLC, United States, under Template. 21 manufacturers in China are registered for this product code.

Vang CR Fem TRL W Pin Hole 65MM RT

Catalogue number SSI002071, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer With Stop 14×14, H06mm

Catalogue number RO0512LA0614X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Standard Face Provisional

14 catalogue numbers from 31-105893, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Fixed Offset Glenosphere Trial 36mm +3 – B, Mini

Catalogue number SSI007023, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

OSS(TM) RS 3CM Resurfacing Femoral

2 catalogue numbers from 32-472131, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Elongated L-Plate Trials

Catalogue number FIS 602, listed by Flower Orthopedics Corporation, United States, under Template. 21 manufacturers in China are registered for this product code.

Vang CR Fem TRL W Pin Hole 70MM LT

Catalogue number SSI002080, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Magec® Rod Template

Trial Rod Template - for use with the MAGEC® Spinal Bracing and Distraction System

Maxim Provisional Tibial Wedge

3 catalogue numbers from 32-341711, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Impix 3d Print

TLIF-O Trial, 15 mm at 6°

Enztec Patella – Depth Gage – S+N

Catalogue number 4240-7380, listed by Enztec Limited, New Zealand, under Template. 21 manufacturers in China are registered for this product code.

High Mobility Mini Humeral Bearing Trial 40mm +3 Ret

2 catalogue numbers from SSI007242, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer 20×12, H13mm

Catalogue number RO1499LG1320X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

T-PAL

T-PAL Trial Spacer 10MM X 28MM 11MM Height

Lordotic Trial Sizer 16×16, H12mm

Catalogue number RO1458LD1216X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Acufex

PCL Twin Tunnel Template

10mm PPK Flex/Ext Gap Checker

Catalogue number SSI005367, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

BI-Polar Modular

7 catalogue numbers from 31-401132, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Reform Poct System

Flexible Rod Template - 250mm

Remedy Stem Size 12 Template

Catalogue number 112-34-1012, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Template

Radiographic Transparency FOR Biomet 3I Parallel Walled Implants

Ossio® Staple Sizing Guide

OSSIO® Staple Sizing Guide.

Unipolar Head

Catalogue number 01.08000.038, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer With Stop 18×12, H07mm

Catalogue number RO0563LE0718X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Triverse Tibia Insert Trial Combo, 59×11

Catalogue number 122-22-8591, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer With Stop 16×14, H06mm

Catalogue number RO0542L20616X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Romeo 2 Instrumentation

Incision Template

Oxford Fixed Lateral

3 catalogue numbers from 32-423357, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

TitanTM

TSS Humeral Stem Trial

Medial Distal Tibial Plate Trials

Catalogue number FIS 650, listed by Flower Orthopedics Corporation, United States, under Template. 21 manufacturers in China are registered for this product code.

Offset Acetabular Augment Provisional

7 catalogue numbers from 31-210154, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

BMP Flexible Osteotome SET

Catalogue number 430050, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Scheker Druj

Ulna Resection Measuring Device

Instruments

Specialty Triathlon CR Femoral Trial With EPI Line

Atoll

Catalogue number 16-40-0903, listed by Seaspine Orthopedics Corporation, United States, under Template. 21 manufacturers in China are registered for this product code.

Subfix

5 catalogue numbers from XFA008090, listed by Stryker GmbH, Switzerland, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer With Stop 14×14, H06mm

Catalogue number RO0312AA0614X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Delta CTA

DELTA CTA TRIAL LATERALIZED HUMERAL CUP, Diameter 36, +3 MM

Template

8 catalogue numbers from SP-1778-T, listed by Biomet Microfixation, United States, under Template. 21 manufacturers in China are registered for this product code.

PSN 0 DEG TIB SZ PLT SZ G, LT

Catalogue number SSI008504, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Elite

Elite Impl Trial Head 22.225MM +3

LZ 12/14 Vsys +0 THD Adpt

Catalogue number SSI006695, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

G7 Snap-In Hi-Wall Prov Size 32 G

Catalogue number SSI008267, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR RT -6MM EXT 40 +3 UNF

Catalogue number SSI007965, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

SureLOK Mini Posterior Cervical/Upper Thoracic System

Rod Template 3.25mm x 150mm

Lorraine Posterolateral Template

Catalogue number B-420036, listed by Bonebridge AG, Switzerland, under Template. 21 manufacturers in China are registered for this product code.

Discovery Elbow Condyle Provisional

Catalogue number 414896, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Guide Wire Ruler

2 catalogue numbers from ODIF05, listed by Orthopedic Designs North America, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Plate Trial

6 catalogue numbers from PS2-08-0065, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Sigma Depuy Reach

Depuy Reach Sigma PS Femoral Trial Size 1.5 Right

Vanguard(TM) RP Stemmed Tray Trial

6 catalogue numbers from 32-488611, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR NE +6MM EXT 36 +0 UNF

2 catalogue numbers from SSI007926, listed by Zimmer, Inc., United States, under Template. 21 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