AcuMatch

Acumatch Collared Medium Neck Trial Second Offset

Registry build 21.09.26
21manufacturers in China registered for this device type
145catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWT
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou AND Science & Technology Development Corp. Zhangjiagang Jiangsu Contract manufacturer 5
Guangzhou Clean Medical Products Manufacturing Corp Guangzhou Guangdong Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Showing 12 of 21. All 21 manufacturers in China registered for Template

Record

Regulatory record for AcuMatch
Listed by Exactech, Inc., United States
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-09-19
Record revised 2025-08-28 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, serial number
Sizes Outer diameter 38 to 70 mm; lumen/inner diameter 22 to 28 mm; angle 15 °
Distribution end date 2024-06-13

Catalogue Numbers

Catalogue numbers for AcuMatch
Catalogue number Size Status
103-44-46 Outer Diameter 46 mm In distribution
199-95-04 11/13 In distribution
103-00-10 10mm In distribution
SPI-044143-64 Outer Diameter 64 mm In distribution
SPI-006230 In distribution
119-95-00 P-SERIES In distribution
103-44-45 Outer Diameter 45 mm In distribution
SPI-044143-44 In distribution
115-24-45 12/14 In distribution
103-22-38 Outer Diameter 38 mm In distribution
103-44-55 Outer Diameter 55 mm In distribution
115-03-45 LARGE In distribution
103-60-07 7mm In distribution
103-60-10 12/14 taper angle In distribution
SPI-044143-70 In distribution
103-44-47 Outer Diameter 47 mm In distribution
115-23-45 LARGE In distribution
103-44-53 Outer Diameter 53 mm In distribution
103-22-55 Lumen/Inner Diameter 22 mm In distribution
103-44-59 Outer Diameter 59 mm In distribution
103-61-10 +10mm Offset In distribution
103-44-44 Outer Diameter 44 mm In distribution
SPI-044143-66 In distribution
117-95-40 12/14 In distribution
135-28-08 Lumen/Inner Diameter 28 mm In distribution
SPI-006231 In distribution
121-91-00 In distribution
SPI-044143-46 In distribution
103-00-05 5mm In distribution
SPI-044143-50 In distribution
SPI-044143-58 In distribution
103-61-07 12/14 Taper Angle In distribution
103-61-03 Taper Angle +3.5mm In distribution
103-22-49 Outer Diameter 49 mm In distribution
103-22-51 Lumen/Inner Diameter 22 mm In distribution
199-95-70 12/14 In distribution
103-44-61 Outer Diameter 61 mm In distribution
SPI-006229 In distribution
103-61-00 12/14 Taper Angle In distribution
103-61-03 12/14 taper angle In distribution
103-22-39 Outer Diameter 39 mm In distribution
103-61-07 7mm In distribution
139-28-10 Angle 15 ° In distribution
113-23-45 LARGE In distribution
103-44-41 Outer Diameter 41 mm In distribution
135-28-06 SIZE F In distribution
103-22-44 Lumen/Inner Diameter 22 mm In distribution
103-61-10 10mm In distribution
100-22-99 In distribution
121-95-00 SIZE 40-42 In distribution
113-03-40 SIZE 2-5 In distribution
103-61-97 12/15 Taper Angle In distribution
103-44-50 Outer Diameter 50 mm In distribution
103-22-48 Outer Diameter 48 mm In distribution
121-00-70 Outer Diameter 70 mm In distribution
103-22-38 Lumen/Inner Diameter 22 mm In distribution
SPI-044143-62 In distribution
103-22-53 Outer Diameter 53 mm In distribution
103-22-47 Lumen/Inner Diameter 22 mm In distribution
131-28-04 Liner Face Angle In distribution
139-28-07 Lumen/Inner Diameter 28 mm In distribution
141-22-07 In distribution
113-23-35 SMALL In distribution
141-22-03 In distribution
SPI-044143-42 In distribution
103-22-50 Lumen/Inner Diameter 22 mm In distribution
139-28-06 Lumen/Inner Diameter 28 mm In distribution
141-22-10 In distribution
SPI-006232 In distribution
141-22-00 In distribution
SPI-044143-60 In distribution
SPI-044143-48 In distribution
SPI-044143-52 In distribution
199-95-03 12/14 In distribution
103-22-39 Lumen/Inner Diameter 22 mm In distribution
113-03-30 In distribution
113-03-45 SIZE 6 In distribution
103-44-11 In distribution
139-28-05 Face Angle, 5mm In distribution
103-00-95 5mm In distribution
103-61-00 12/14 taper angle In distribution
103-44-57 Outer Diameter 57 mm In distribution
115-23-40 12/14 In distribution
199-95-71 11/13 In distribution
103-22-43 Lumen/Inner Diameter 22 mm In distribution
103-61-97 3.5mm In distribution
103-44-11 In distribution
103-44-48 Outer Diameter 48 mm In distribution
113-23-40 MEDIUM In distribution
103-60-97 3.5mm In distribution
103-22-45 Outer Diameter 45 mm In distribution
113-05-40 SIZE 2-5 In distribution
103-44-52 Outer Diameter 52 mm In distribution
135-28-07 Lumen/Inner Diameter 28 mm In distribution
107-95-00 In distribution
SPI-006233 In distribution
103-44-40 Outer Diameter 40 mm In distribution
139-28-09 SIZE J In distribution
103-00-00 0mm In distribution
SPI-044143-56 In distribution
119-95-20 12/14 In distribution
103-22-46 Lumen/Inner Diameter 22 mm In distribution
103-44-49 Outer Diameter 49 mm In distribution
103-22-56 Outer Diameter 56 mm In distribution
SPI-044143-68 In distribution
103-60-00 12/14 taper angle In distribution
103-44-51 Outer Diameter 51 mm In distribution
135-28-05 Lumen/Inner Diameter 28 mm In distribution
103-22-52 Outer Diameter 52 mm In distribution
103-44-42 Outer Diameter 42 mm In distribution
103-44-43 Outer Diameter 43 mm In distribution
115-24-35 12/14 In distribution
139-28-08 SIZE H In distribution
135-28-10 Lumen/Inner Diameter 28 mm In distribution
113-05-35 SIZE 1 In distribution
135-28-09 Lumen/Inner Diameter 28 mm In distribution
117-95-01 12/14 In distribution
115-04-40 MED In distribution
103-44-54 Outer Diameter 54 mm In distribution
SPI-044143-54 In distribution
113-03-35 SIZE 1 In distribution
113-05-45 SIZE 6 In distribution
103-22-54 Lumen/Inner Diameter 22 mm In distribution
115-24-40 MEDIUM In distribution
103-60-03 3.5mm In distribution
115-05-45 LARGE Withdrawn
103-22-42 Outer Diameter 42 mm Withdrawn
151-95-00 Withdrawn
151-01-01 0mm Withdrawn
115-04-35 SMALL Withdrawn
151-01-06 0mm Withdrawn
115-03-40 12/14 Withdrawn
151-01-05 5mm Withdrawn
151-01-02 M-SERIES Withdrawn
115-23-35 12/14 Withdrawn
115-04-45 12/14 Withdrawn
115-05-40 MEDIUM Withdrawn
151-01-95 M-SERIES Withdrawn
115-03-35 12/14 Withdrawn
151-01-07 10mm Withdrawn
151-01-03 20mm Withdrawn
115-05-35 SMALL Withdrawn
103-22-41 Outer Diameter 41 mm Withdrawn
151-01-04 30mm Withdrawn
103-22-40 Outer Diameter 40 mm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Attune Depuy (Ireland) 1,385
Template Exactech, Inc. 1,277
4WEB Medical 4WEB Inc. 991
Evolution® Microport Orthopedics Inc. 966
Template Zimmer, Inc. 792
Advance® Microport Orthopedics Inc. 644
Apex Knee System Omni Life Science, Inc. 635
Profemur® Microport Orthopedics Inc. 591
Link Instruments – Trial implants and size gauges Waldemar Link GmbH & Co. KG 549
Template Synthes Gmbh 516
Optetrak Logic Exactech, Inc. 512
Template Depuy Spine, Inc. 451

Showing 12 of 2,940. All products under Template

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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