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.

Prostalac

PROSTALAC FEMORAL TRIAL SIZE 3 200mm RIGHT

Provisional

7 catalogue numbers from 31-473726, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Kheiron

L500mm rod template

Anatomic Trial Sizer With Stop 20×14, H05mm

Catalogue number RO0401AH0520X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR NE +0MM EXT 36 +3 UNF

Catalogue number SSI007923, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Guide Arm

3 catalogue numbers from ODIT103, listed by Orthopedic Designs North America, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

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

Catalogue number SSI007024, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

LPS

LPS SEGMENTAL COMPONENT TRIAL 125mm

TraumaOne System

14 catalogue numbers from 46-1021T, listed by Biomet Microfixation, United States, under Template. 21 manufacturers in China are registered for this product code.

TriVerse AS Tibia Insert Trial, 87-91×12

Catalogue number 122-22-6872, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Taperloc Complete Neck Trunnion

4 catalogue numbers from 51-221000, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

PathFinder NXT Minimally Invasive Pedicle Screw System

Targeting Incision Guide Template

Template

Alif Trial

Biomet® Tibial Trial

9 catalogue numbers from 32-341260, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer With Stop 16×14, H12mm

Catalogue number RO0548L21216X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer 14×14, H08mm

Catalogue number RO1214AA0814X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

PSN Tasp Prov BTM R GH +3MM

Catalogue number SSI007777, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

PLR(TM) Splined Revision Femoral

11 catalogue numbers from 31-158321, 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, H12mm

Catalogue number RO0308A11214X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Trial CUP D72 Mm

2 catalogue numbers from H0030157009, listed by HPF SRL, under Template. 21 manufacturers in China are registered for this product code.

Advantium

3 catalogue numbers from 18410104, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Articul/EZE S-ROM

Srom Articuleze Neck Trial 36+12LAT

PSN Tasp Prov BTM L J +3MM

Catalogue number SSI007778, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Citrelock ACL 8mm Sizing Tube

Catalogue number 40-103-0018, listed by Acuitive Technologies, United States, under Template. 21 manufacturers in China are registered for this product code.

Identity Humeral

5 catalogue numbers from 110047182, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Fusion Trial Trunnion Sleeve +4mm

2 catalogue numbers from 112-32-0247, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

All Poly Monotrial UC

9 catalogue numbers from 122-18-0476, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Sz 4 NG Stm Tib Prov – Metal

Catalogue number SSI006318, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Trial CUP D42 Mm

2 catalogue numbers from H0030151009, listed by HPF SRL, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer 18×14, H13mm

Catalogue number RO1479LF1318X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

PSN 0 DEG TIB SZ PLT SZ A, RT

Catalogue number SSI008493, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

SSI DST Agmt Prov F 5MM

Catalogue number SSI006519, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

TriVerse AS Tibia Insert Trial, 67×16

Catalogue number 122-22-6676, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Agilon® XO Trial Glenoid

4 catalogue numbers from 78020043, listed by implantcast GmbH, Germany, under Template. 21 manufacturers in China are registered for this product code.

Ringloc Screw-IN Provisional

Catalogue number 31-115806, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Cordera Hip System

Cordera Stem Acetate 110 percent Magnification Template

NexGen LPS Flex

18 catalogue numbers from SSI004879, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Bi-Polar

10 catalogue numbers from 110005109, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Timberline MPF Lateral Modular Plate Fixation System

Lateral Trial 18W X 12H X 14D

PSN PS Prov 10-12 J, L

5 catalogue numbers from 82-0156-876-94, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

OSS™ Letson™

2 catalogue numbers from 32-472088, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Micronail

Smooth Trial

Contact PEEK IBF System

CONTACT, 30x10x0deg TAPERED TRL SPACER

LinkSymphoKnee

Knee tibia prosthesis trial - LinkSymphoKnee

World Cup Templates 58-64mm

Catalogue number 112-43-0002, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Evolve Template 37.5mm Size 1

Catalogue number 111-242-302, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Osteotec Silicone Finger Implant Sizer Size 6

Catalogue number OSTF-S6, listed by Osteotec Limited, United Kingdom, under Template. 21 manufacturers in China are registered for this product code.

Ahsad

Assist to Hairline Surface Area Determination. Can assist in surface for donor or receipient area.

Sierra

Occiptal Rod Template, 75 Degrees

MDI

Sizer

Osteotec Silicone Finger Implant Sizer Size 8

Catalogue number OSTF-S8, listed by Osteotec Limited, United Kingdom, under Template. 21 manufacturers in China are registered for this product code.

X FIX

6 catalogue numbers from 05025, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Compress® Trial Spindle

3 catalogue numbers from 32-481083, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer 20×16, H06mm

Catalogue number RO1312AI0620X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Rasp Provisional Head/Neck

3 catalogue numbers from 31-400654, listed by Biomet UK Ltd., United Kingdom, under Template. 21 manufacturers in China are registered for this product code.

Zyston Interbody Spacer System

STR Trial 17HX25LX10W Lordotic

Riva Posterior Fixation System

Screw Measurement and Holder

Volt™ Wrist Treatment System

Sizing Template f/2Column Dist Radius Plate/14Shaft/Standard

MP Monoblock – Instruments

12 catalogue numbers from 136-064/00, listed by Waldemar Link GmbH & Co. KG, Germany, under Template. 21 manufacturers in China are registered for this product code.

Maxim P.S. Femoral Component

12 catalogue numbers from 32-345113, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Truliant CC

Truliant FIT Augment Trial 1/2 RL SZ 4.5,10MM

BIO-Modular Shoulder

Catalogue number 406601, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Tspace Peek/XP

Tspace PEEK/XP/3D Trial 5° 26X11.5X13MM

PSN 0 DEG TIB SZ PLT SZ H, LT

Catalogue number SSI008506, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Oxford Fixed

5 catalogue numbers from 32-423349, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR LT +0MM EXT 36 +0 UNF

Catalogue number SSI007950, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR NE -6MM EXT 40 +3MM RET

2 catalogue numbers from SSI007858, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

T.e.s.s. HUM Offset Trial Head

6 catalogue numbers from A1700216, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

AnatomyPrint

Anatomy Print Model Poly

Endoskeleton® TO

Trial, Oblique, 11mm

Modular Reach Rasp/Provisional

4 catalogue numbers from 31-108293, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Ascent Knee Instrument

2 catalogue numbers from 32-379495, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Template

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

Triverse Tibia Insert Trial Combo, 79-83×13

Catalogue number 122-22-8933, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer 16×12, H09mm

Catalogue number RO1235AC0916X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

VBR-S Device

Vertebral Body Replacement – Provisional

Lordotic Trial Sizer 16×12, H04mm

Catalogue number RO1430LC0416X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Conformity Stem

Neck template ruler

TriVerse X-Ray Digital Template, PS Femur

20 catalogue numbers from 02-039-95-1367, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Ringloc®+ MAX-ROM Liner Provisional

16 catalogue numbers from 33-106885, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Implant Style Provisional

12 catalogue numbers from 31-400664, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Triverse Tibia Insert Trial Combo, 63-67×13

Catalogue number 122-22-8373, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Stabolt

Trial Attachment FOR 4-HOLE Plate

AMP

LIF AMP Template, 1315

BI-Metric Revision Provisional

7 catalogue numbers from 31-473648, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

TriVerse AS Tibia Insert Trial, 75×10

Catalogue number 122-22-6750, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Cross-Fuse II PEEK IBF System

Crossfuse II 14X13 Angled Trial

G7 Snap-In Hi-Wall Prov Size 28 D

Catalogue number SSI008256, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

IQ Vega System PS

IQ Vega PS Tray Trial Components Femur 2

Pure Pectus

Template, Pectus BAR, Angled, Aluminum

Compress(R)

9 catalogue numbers from 32-481009, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer 14×12, H12mm

Catalogue number RO1408L11214X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Evans Trial

TMC Evans Trial, 12mm

XM Shaft Single End Trial

Catalogue number 132-25-0021, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

SSI DST Agmt Prov B 15MM

Catalogue number SSI006527, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

BIO-Modular Reverse Instruments

12 catalogue numbers from 405650, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer With Stop 14×12, H05mm

Catalogue number RO0501L10514X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

HUM TR NE +6MM STD 40 +0MM RET

Catalogue number SSI007897, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Taperloc® Head / Neck Trial

4 catalogue numbers from 31-478148, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Motoband Instruments

Dynamet Linked Template - 15MM Narrow JI

Ascent(TM) Anterior Stabilized Prov.

2 catalogue numbers from 32-379842, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer 20×16, H05mm

Catalogue number RO1511LI0520X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Lordotic Trial Sizer 18×16, H11mm

Catalogue number RO1487L31118X16, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Vital Spinal Fixation System

PSO Angular Template 35°

40MM +3 – C Offset Glenosphere Trial

Catalogue number SSI008395, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Cellbrick Knee Spacer

Femoal spacer sizing template, #4~#5

Columbus CR/PS

Adapter Trial Fem.stem 7°LAT.57MM C'less

Template 14.0MM/SQUARE

Catalogue number 16976, listed by Biopro, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer With Stop 16×14, H11mm

Catalogue number RO0347A21116X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

36 MM BRG STD Tray STD +6 TPR

Catalogue number SSI007311, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Endoskeleton® TA VBR

Trial, 7 Deg Lordotic, Standard, 18mm

OSS(TM) RS 71MM NON-Modular

2 catalogue numbers from 32-472166, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Anca-FIT™

8 catalogue numbers from PPR67868, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Profemur®metal

17 catalogue numbers from APA12154, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Anatomic Trial Sizer With Stop 16×14, H05mm

Catalogue number RO0341A20516X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Line

Catalogue number APA04770, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

MIS Guide, Small

Catalogue number CPF 992, listed by Flower Orthopedics Corporation, United States, under Template. 21 manufacturers in China are registered for this product code.

TriVerse AS Tibia Insert Trial, 79-83×16

Catalogue number 122-22-6796, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Compress® Male/OSS™ Female

Catalogue number 32-481073, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Diamond Carpal

Carpal Fusion Plate Trial Plate, L

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