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.

Anatomic Trial Sizer With Stop 14×14, H13mm

Catalogue number RO0319AA1314X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

OSS(TM) RS 9CM Proximal Tibial

Catalogue number 32-472152, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

SSI DST Agmt Prov F 15MM

Catalogue number SSI006531, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

b-ONE™ 12/14 Taper Femoral Head

Head Trial, 28MM Diameter, -3.5MM Neck Length

Comp Rvs 41mm Translucent Glenopshere Prov +6

Catalogue number SSI006998, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer 14×16, H05mm

Catalogue number RO1421LB0514X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

OSS Proximal Femoral Resection Template

Catalogue number 110018800, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Coral

Rod Template - 5.0mm x 450mm

Acis

Acis Standard Lordotic Trial With Stop 11MM-12MM

TM Ardis Interbody System

TM Ardis® Interbody System 7MM Provisional Case

Mallory/Head® XR Series Lateralized

7 catalogue numbers from 31-104333, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

G7 Snap-In Hi-Wall Prov Size 40 G

Catalogue number SSI008269, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

TriVerse X-Ray Template Set

Catalogue number 02-039-95-0195, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Longboard Trial Neck HO

Catalogue number 111-552-512, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Z2B 6-LEG Adapter

Catalogue number SSI005623, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Attunetm

ATTUNETM MAKE TO ORDER FEMORAL TRIAL SHIM 2mm THICK

SignaSure Trial Shell

12 catalogue numbers from 112-35-0460, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Remedy Stem Size 10 Template

Catalogue number 112-34-1010, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Citrelock ACL 10mm Sizing Tube

Catalogue number 40-103-0012, listed by Acuitive Technologies, United States, under Template. 21 manufacturers in China are registered for this product code.

Virage®

4 catalogue numbers from 07.01767.001, listed by Zimmer Biomet Pty Ltd, Australia, under Template. 21 manufacturers in China are registered for this product code.

Endoskeleton® TT

Trial, 4 Deg Lordotic, Curved, 12mm

Evolve Template 50.0mm Size 4

Catalogue number 111-242-313, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer With Stop 16×14, H12mm

Catalogue number RO0348A21216X14, 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 44 H

Catalogue number SSI008273, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR NE +12MM EXT 36 +3 UNF

Catalogue number SSI007931, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Lactosorb* 1.5MM System Template

11 catalogue numbers from 914-2422, listed by Biomet Microfixation, United States, under Template. 21 manufacturers in China are registered for this product code.

LCU Hip System – Instruments

Surgical implant template, reusable - LCU Hip System

Catalystem

Catalystem Trial Neck Size 7-12 Standard Offset

Anatomic Trial Sizer With Stop 16×16, H07mm

Catalogue number RO0353AD0716X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

X-Mesh

X-Mesh Expandable Cage System Trial, Posterior, Small/Medium

Anatomic Trial Sizer With Stop 16×14, H04mm

Catalogue number RO0340A20416X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer With Stop 18×14, H13mm

Catalogue number RO0379AF1318X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

28 MM Cemented HI-Wall

Catalogue number 423531, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

General Instruments

Hook Trial 5597173 Extended Body M-L

Anatomic Trial Sizer With Stop 18×12, H10mm

Catalogue number RO0366AE1018X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Prospace

Prospace Peek Trial Implant 5° 10X26MM

Fixed Offset Glenosphere Trial 36mm +6 – D, Mini

Catalogue number SSI007030, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Illico

Guidewire Measurement Ruler

Facet Fixx™ Facet Screw System

DTS Guide, Dilator 2

Oracle

Oracle Trial Spacer 15MM HEIGHT/0 DEG Angle

Newclip Instruments

15 catalogue numbers from ANC1866, listed by Newclip Technics SAS, France, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer 14×12, H05mm

Catalogue number RO1401L10514X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Neofit

Neofit Trial Plate Size 45 MM

Pit’stop®

Pit'stop Trial Implant Size 14 MM

Maxim Primary Provisional Trial

5 catalogue numbers from 32-341936, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Spinal Hook System

5 catalogue numbers from SH1748, listed by CG MedTech Co., Ltd., South Korea, under Template. 21 manufacturers in China are registered for this product code.

Template, X-RAY, Tibial Nail

Catalogue number 1203, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

TriVerse AS Tibia Insert Trial, 79-83×14

Catalogue number 122-22-6794, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer With Stop 14×16, H11mm

Catalogue number RO0327AB1114X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Interspinous Plate System

28mm Trial

Genesis II

Thinned Spacer Block

TriVerse AS Tibia Insert Trial, 87-91×14

Catalogue number 122-22-6874, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Metal Hemi

Implant Trial

Elite Plus

Elite Plus Trial Head 32MM DIA X -3MM

PSN Stem TIB Prov 5 DEG SZ a R

Catalogue number SSI006880, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Tibial Trial Tray

10 catalogue numbers from 122-18-0312, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

XIA

Blocker Inserter

40MM +3 – E Offset Glenosphere Trial

Catalogue number SSI008397, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer 14×16, H12mm

Catalogue number RO1428LB1214X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR NE +12MM STD 36 +0MM STD

Catalogue number SSI007899, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

HO FPP Prov Neck L7-10

Catalogue number SSI007182, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

LPT

Great Toe Regular Trial

G7 Snap-In Hi-Wall Prov Size 32 B

Catalogue number SSI008253, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

NuGrip CMC

Nugrip Template SZ. L

Trial CUP D74 Mm

2 catalogue numbers from H0030157409, listed by HPF SRL, under Template. 21 manufacturers in China are registered for this product code.

Global APG+

GLOBAL APG+ SIZER PIN GUIDE SIZE 52 +0mm

Reef

5 catalogue numbers from L93577, listed by Depuy (Ireland), Ireland, under Template. 21 manufacturers in China are registered for this product code.

NuGrip® CMC Implant System

Integra® NuGrip® The NuGripTemplate is used to assess coverage and establish sizing for a component.

Trial CUP D45 Mm

2 catalogue numbers from H0030151609, listed by HPF SRL, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer 16×16, H05mm

Catalogue number RO1251AD0516X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

12x14mm, 8mmx0° Kodiak Cervical Trial

Catalogue number 07-0018H, listed by Met 1 Technologies, LLC, United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer With Stop 18×12, H05mm

Catalogue number RO0561LE0518X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Distal Radius Plate Trials, 2.0mm Volar, Wide

Catalogue number FIM 300, listed by Flower Orthopedics Corporation, United States, under Template. 21 manufacturers in China are registered for this product code.

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

Catalogue number SSI007905, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Salti Medial Template

Catalogue number B-420041, listed by Bonebridge AG, Switzerland, under Template. 21 manufacturers in China are registered for this product code.

Streamline TL Spinal Fixation System

3 catalogue numbers from 10-RODTEMPLATE, listed by Pioneer Surgical Technology, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer 16×16, H04mm

Catalogue number RO1450LD0416X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

40 MM BRG STD Tray +10 0 TPR

Catalogue number SSI007321, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer With Stop 14×16, H11mm

Catalogue number RO0527LB1114X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Comp Rvs 36mm Translucent Glenopshere Prov +3

Catalogue number SSI006991, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Distraction System

4 catalogue numbers from 914-3110, listed by Biomet Microfixation, United States, under Template. 21 manufacturers in China are registered for this product code.

Repicci II® Tibial Trial

3 catalogue numbers from 32-454979, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

14x16mm, 5mmx6° Kodiak Cervical Trial

Catalogue number 07-0036J, listed by Met 1 Technologies, LLC, United States, under Template. 21 manufacturers in China are registered for this product code.

Olecranon Plate Trial

Catalogue number 2312-18-600, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR LT +0MM EXT 36 +0MM RET

Catalogue number SSI007799, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Humeral BI-Polar

7 catalogue numbers from 408404, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Provisional Head/Neck

12 catalogue numbers from 31-473444, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer 16×16, H11mm

Catalogue number RO1257AD1116X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Endo/BI-Polar Trial Head

13 catalogue numbers from 31-401156, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Arsenal

250mm ROD TEMPLATE

Securespan

Securespan Drill BIT F/Dr.guide FG868R

Insert

5 catalogue numbers from APA05850, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Origin Size 16 Template

Catalogue number 112-212-116, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer 14×16, H05mm

Catalogue number RO1221AB0514X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

22mm Polarcup Unipolar Conversion +4mm

Catalogue number 35130048, listed by Enztec Limited, New Zealand, under Template. 21 manufacturers in China are registered for this product code.

TriVerse AS Tibia Insert Trial, 87-91×10

Catalogue number 122-22-6870, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Link Instruments – Sterilization Container and Trays

Knee tibia prosthesis trial - LINK SLED Prosthesis

RX 90(R) Provisional Liner

6 catalogue numbers from 429043, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Integral 180 Reduced Proximal

Catalogue number 31-166111, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Delta Xtend

Delta Xtend X-RAY Template

VerSys Heritage®

2 catalogue numbers from 7894-09-57, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

OSS(TM) Distal Segmental

4 catalogue numbers from 32-472004, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

A.l.p.s.fibula Anatomic Locking Trial

3 catalogue numbers from 8162-06-110, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer 20×14, H09mm

Catalogue number RO1505LH0920X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Maxim Primary Lipped

15 catalogue numbers from 32-346358, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

A.r.t.™template, X-RAY, Femoral Nail

Catalogue number 20048, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Irix-C Cervical Integrated Fusion System

Specialty 11/12 Irix-C Double END 16X13 Parallel Trial Assy W/O Stops

A.l.p.s Hand Fracture Systemlock Y Plate Trial

2 catalogue numbers from 231221253, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Endoskeleton™ TL Interbody System

Trial 7230-1516 TLH 30 DEG 22X 16MM

Lordotic Trial Sizer With Stop 18×12, H11mm

Catalogue number RO0567LE1118X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR LT +0MM EXT 40 +0MM STD

Catalogue number SSI007797, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Origin Stem Size 9 Template

Catalogue number 112-212-159, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Exact/Alliance Instrumentation

3 catalogue numbers from X31-400273, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

MAX-TI(R) Acetabular

2 catalogue numbers from 12-124080, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

FX RPP Lateral Prov Neck L 11-14

Catalogue number SSI007195, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

MultiCup™

MultiCup Trial Inlay 41 mm/ Innerdia 32 mm Standard without rim (for Cups 50/56 mm) non-sterile

Template

Template H11

Misc Instruments and Sterilization Trays

2.5MM Cannulated Drill

Expedium

EXPEDIUM SPINE SYSTEM PEDICLE SCREW SIZER 4.35mm

Sizer 9MM

Catalogue number 17186, 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