PRO-Spec

Cotton Osteotomy Trial 20MMX5.5MM

Registry build 21.09.26
21manufacturers in China registered for this device type
44catalogue 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 PRO-Spec
Listed by Crossroads Extremity Systems LLC, United States
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
Establishment Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2025-03-07
Record revised 2026-03-04 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for PRO-Spec
Catalogue number Size Status
EVANS OSTEOTOMY TRIAL 22MMX6MM In distribution
LAPIDUS TRIAL 10MM In distribution
SUB-TALAR TRIAL 10MM In distribution
EVANS OSTEOTOMY TRIAL 20MMX6MM In distribution
MTP TRIAL 18MM x 20MM In distribution
EVANS OSTEOTOMY TRIAL 22MMX10MM In distribution
MTP TRIAL 20MM x 10MM In distribution
EVANS OSTEOTOMY TRIAL 22MMX12MM In distribution
COTTON OSTEOTOMY TRIAL 20MMX5.5MM In distribution
EVANS OSTEOTOMY TRIAL 20MMX10MM In distribution
EVANS OSTEOTOMY TRIAL 20MMX12MM In distribution
LAPIDUS TRIAL 14MM, UNIVERSAL In distribution
SUB-TALAR TRIAL 12MM In distribution
COTTON OSTEOTOMY TRIAL 20MMX6.5MM In distribution
EVANS OSTEOTOMY TRIAL 22MMX8MM In distribution
EVANS OSTEOTOMY TRIAL 18MMX8MM In distribution
LAPIDUS TRIAL 5MM In distribution
COTTON OSTEOTOMY TRIAL 20MMX4.5MM In distribution
MTP TRIAL 18MM X 5MM In distribution
EVANS OSTEOTOMY TRIAL 18MMX12MM In distribution
CALC-CUBOID TRIAL 8MM In distribution
MTP TRIAL 18MM x 8MM In distribution
COTTON OSTEOTOMY TRIAL 16MMX6.5MM In distribution
COTTON OSTEOTOMY TRIAL 16MMX7.5MM In distribution
MTP TRIAL 18MM x 15MM In distribution
CALC-CUBOID TRIAL 10MM In distribution
SUB-TALAR TRIAL 18MM In distribution
CALC-CUBOID TRIAL 12MM In distribution
CALC-CUBOID TRIAL 16MM In distribution
EVANS OSTEOTOMY TRIAL 18MMX10MM In distribution
MTP TRIAL 18MM x 10MM In distribution
SUB-TALAR TRIAL 14MM In distribution
CALC-CUBOID TRIAL 14MM In distribution
LAPIDUS TRIAL 12MM In distribution
SUB-TALAR TRIAL 16MM In distribution
COTTON OSTEOTOMY TRIAL 16MMX5.5MM In distribution
MTP TRIAL 20MM x 8MM In distribution
LAPIDUS TRIAL 8MM In distribution
COTTON OSTEOTOMY TRIAL 16MMX4.5MM In distribution
CALC-CUBOID TRIAL 18MM, UNIVERSAL In distribution
MTP TRIAL 20MM x 5MM In distribution
EVANS OSTEOTOMY TRIAL 20MMX8MM In distribution
COTTON OSTEOTOMY TRIAL 20MMX7.5MM In distribution
EVANS OSTEOTOMY TRIAL 18MMX6MM In distribution

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