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.

Vanguard XP

28 catalogue numbers from 32-700424, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Slim Trunnion HO Neck 15-21

Catalogue number SSI007204, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Reclaim

Reclaim Monobloc Revision HIP System Monobloc X-RAY Template 120% K

TriVerse AS Tibia Insert Trial, 59×20

Catalogue number 122-22-6599, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Jaguar Lumbar I/F Cage

JAGUAR LUMBAR I/F CAGE SYSTEM WEDGED TRIAL SPACER 11 x (11 x 13) x 25mm

Titan Humeral Resurfacing Arthroplasty

Humeral Sizer/Centralizer SZ. 44-15

Megasystem-C Tumor- and Revision System – Instruments

Knee femur prosthesis trial - Megasystem-C Tumor- and Revision System

Matira

Drill Guide, Variable, Attached Handle

ATB

Anterior Tension Band Template TWO Level Symmetrical 105MM

Biomet Series A

4 catalogue numbers from 32-484788, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Sigma High Performance

Sigma High Performance FBT Standard Tibial Punch Guide Size 1.5-4

Trial CUP D62 Mm

2 catalogue numbers from 9055.28.462, listed by HPF SRL, under Template. 21 manufacturers in China are registered for this product code.

DVR® Anatomic Wide Head Right Trial

Catalogue number 2312-12-111, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

MP Tibial Tray Template

7 catalogue numbers from 32-484502, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

UNI-Elbow

Radio Capitellum, Resection Guide, LG

Tibial Trial CR Insert

8 catalogue numbers from 122-10-0534, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

OSS Distal Resurfacing

4 catalogue numbers from 32-472000, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

ShurFit Interbody Device

TLIF Sizer 11mm x 30mm

A.l.p.s.distal Tibia Anterolateral Plate Trial – Narrow Right

6 catalogue numbers from 8163-06-309, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Citrelock ACL 9mm Sizing Tube

Catalogue number 40-103-0011, listed by Acuitive Technologies, United States, under Template. 21 manufacturers in China are registered for this product code.

MSB Reusable Instruments

ROD Template 3650013 ROD Tmplate 3.2/3.5

Spii Model Lubinus Hip Stem – Instruments

Surgical implant template, reusable - SPII Model Lubinus Hip Stem

MobileLink Acetabular Cup System – Instruments

Acetabulum prosthesis trial, reusable - MobileLink Acetabular Cup System

Implant Style Ring-LOC

19 catalogue numbers from 31-433762, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

AGC PS Femoral Component

3 catalogue numbers from 32-468003, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer 20×16, H08mm

Catalogue number RO1514LI0820X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

TriVerse X-Ray Digital Template, CR Femur

20 catalogue numbers from 02-039-95-3355, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Freedom Ringloc-X Instrumentation

12 catalogue numbers from 31-117017, listed by Biomet UK Ltd., United Kingdom, under Template. 21 manufacturers in China are registered for this product code.

Recap HIP Instrumentation

24 catalogue numbers from 31-500948, listed by Biomet UK Ltd., United Kingdom, under Template. 21 manufacturers in China are registered for this product code.

Micro-Mill® NexGen®

6 catalogue numbers from 5978-31-03, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Shoreline ACS

Trial 16x12x12mm, 7 Deg Lordosis, w/ Depth Stop

Origin DAA Trial Neck SO

Catalogue number 111-182-023, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

In2Bones

Anterior Plate, 3H, Right, Trial, NON-Sterile

Extend®

23 catalogue numbers from 47971950, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR NE +12MM EXT 40 +0MM RET

Catalogue number SSI007881, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

BethaLoc®

trial neck snap

OSS™ Interlok®

8 catalogue numbers from 32-472115, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Conmed

High Strength Guide PIN, 12 IN, Sterile, 2.4 X 305 MM (.093 X 12 IN)

Lordotic Trial Sizer 16×14, H04mm

Catalogue number RO1440L20416X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Preserve Bone Wedge Trials

3D Printed Lapidus Trial, 4mm, 0Deg

Juliet® Ti

Trial Implant TI PO/OL Small Width L36 W8.5 H10

Biofoam

Evans Wedge Trial

HUM TR NE +12MM EXT 36 +0 UNF

Catalogue number SSI007930, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

General Instrument

Prime NM 31X24mm All-In-One Trial 14mm 10Deg

Integra®

LMP System Implant Trial Sizer 40 The trial sizers are used to select the correct size implant, and to be certain that all soft contractures have been released. It is important to load the…

SMR System

SMR System - Reverse Trial Liner LAT. Dia.40mm Medium

R3

Screw-IN R3 20 Degree Trial Acetabular Liner Tray

Steinmann PIN/Trocar Point

2 catalogue numbers from 32-362078, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

HI-Wall Ringloc® Screw-IN

23 catalogue numbers from 31-107926, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Unity Knee System

Corin Tibial Baseplate trial, sz 4

HUM TR NE +0MM STD 40 +3MM RET

Catalogue number SSI007890, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

BIO-Modular(R) Shoulder

12 catalogue numbers from 406655, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Copeland(TM) Humeral Provisional

8 catalogue numbers from 402631, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

LP Ring LOC Provisional Liner

16 catalogue numbers from 31-423567, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Acetabular Shell Gauge

Catalogue number 31-177978, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Aria Size 11 Template

Catalogue number 111-201-511, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Trial Cups

18 catalogue numbers from 112-152-193, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

MCP System

MCP. Trial. Proximal. SZ. 50

Provisional CUP

10 catalogue numbers from 31-475306, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Provisional TRI-Polar

6 catalogue numbers from 31-165110, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

PSN Stem TIB Prov 5 DEG SZ B L

Catalogue number SSI006881, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Surgical Instruments

Sizing Template. PHS SZ. 20

Anatomic Trial Sizer With Stop 20×12, H12mm

Catalogue number RO0398AG1220X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Slim Trunnion HO Neck 7-10

Catalogue number SSI007202, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Anterior Cervical Interbody Fusion Device

5° & 10° X 10mm Trial Assembly

Alif Vertigraft

Universal Alif Instrument SET Vertigraft Trial, Anterior 20

Evolve Template 50.0mm Size 2

Catalogue number 111-242-311, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Vanguard XP® Instrumentation

33 catalogue numbers from 32-700003, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

DVR® Crosslock Epak™plate Sizing Template SET

Catalogue number 212000010, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Ulna Provisional Bearing

Catalogue number SSI007375, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

TriVerse AS Tibia Insert Trial, 59×18

Catalogue number 122-22-6598, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Sigma Pathway

Sigma Pathway Anterior Down Femoral Sizing Guide

40MM +3 – B Offset Glenosphere Trial

Catalogue number SSI008394, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Repicci II(R) Tibial Trial

12 catalogue numbers from 32-454984, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Integral 180 Primary/Revision Prov.

6 catalogue numbers from 31-166015, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Sigma High Performance

Sigma High Performance 150 Fixed Reference AP Block Size 2.5

M2a-Magnum™

24 catalogue numbers from 31-173756, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

G7 Snap-In Neutral Prov Size 28 E

Catalogue number SSI008230, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Lacey™

5 catalogue numbers from 22610022, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer 14×12, H08mm

Catalogue number RO1404L10814X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Construx – Mini Ti,CONSTRUX – Mini PEEK Vbr,construx – Mini PTC

DOUBLE ENDED TRIAL, 15mm W X 15mm L, 15° LORDOTIC - 10mm/11mm H

Anatomic Trial Sizer With Stop 18×12, H06mm

Catalogue number RO0362AE0618X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

G7 Snap-In Neutral Prov Size 36 F

Catalogue number SSI008235, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR NE +0MM Xext 40 +0MM RET

Catalogue number SSI007841, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Osteotec Silicone Finger Implant Sizer Size 1

Catalogue number OSTF-S1, listed by Osteotec Limited, United Kingdom, under Template. 21 manufacturers in China are registered for this product code.

A.l.p.s.® Clavicle Plating System

3 catalogue numbers from 233500011, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Vanguard® Instruments

4 catalogue numbers from 32-483908, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Integra® Freedom Wrist Arthroplasty System

Integra® Freedom Wrist Arthroplasty System Radial Template, Size 1

Columbus PS

Columbus PS Removable Trial Fem.gauge F6

OSS(TM) RS 63MM NON-Modular

2 catalogue numbers from 32-472164, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer With Stop 14×12, H07mm

Catalogue number RO0303A10714X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Triverse Tibia Insert Trial Combo, 79-83×22

Catalogue number 122-22-8942, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

World Stem Template Size 5

Catalogue number 112-42-3005, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Maxim Revision Femoral Component

3 catalogue numbers from 32-345211, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Regenerex

16 catalogue numbers from 32-484605, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer 20×16, H08mm

Catalogue number RO1314AI0820X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR RT -6MM EXT 36 +0 UNF

Catalogue number SSI007962, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Activ C

Activ C Trial Implant Flat Size XXL 6MM

AGC PS Tibial Trial

30 catalogue numbers from 32-470078, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Provisional Modular Head

23 catalogue numbers from 31-473308, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Ortholoc 3di

5 catalogue numbers from 58A9REVT, listed by Wright Medical Technology, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Vanguard® SSK Constrained

8 catalogue numbers from 32-482248, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

ReCap®

11 catalogue numbers from 31-500942, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Struxxure™ Anterior Cervical Plate and Screws

Drill Guide, Double Barrel, Fixed, 15°, Long

Resorb X

Template, Large Grid, Titanium

TriVerse AS Tibia Insert Trial, 87-91×15

Catalogue number 122-22-6875, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Mallory/Head(R) Lateralized

10 catalogue numbers from 104384, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Fortilink®-TS IBF System

FORTILINK-TS 16x22mm 12DEG LORDOTIC TRIAL SPACER

H&F Plate Trials, 1.5mm

Catalogue number FIS 400, listed by Flower Orthopedics Corporation, United States, under Template. 21 manufacturers in China are registered for this product code.

Concept Grafix

Concept Grafix Graft Preparation Table

PyroCarbon Lunate

Lunate Sizing Template SZ. 04

95 DEG Guide PIN Template

Catalogue number 456471, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

TriVerse AS Tibia Insert Trial, 75×11

Catalogue number 122-22-6751, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

HUM TR RT +0MM EXT 40 +0 UNF

Catalogue number SSI007960, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Summit

SUMMIT SI OCT SPINAL FIXATION SYSTEM TEMPLATE, DUAL DIAMETER ROD 420mm

Vang CR Fem TRL W Pin Hole 75MM RT

Catalogue number SSI002075, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Excia L

Excia L 12/14 Trial Neck F/Form Profiler

Max-ROM™ RingLoc® Acetabular System

33 catalogue numbers from 31-156235, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Vanguard® SSK

32 catalogue numbers from 32-482142, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Sizing Guide 15MM

Catalogue number 19809, listed by Biopro, 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