Healix

Cannulated Headless Hammertoe Screw 2.5mmD, 45mmL. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon…

Registry build 21.09.26

Cannulated Headless Hammertoe Screw 2.5mmD, 45mmL. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

31manufacturers in China registered for this device type
257catalogue numbers in this listing
8510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWC
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11

Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone

Record

Regulatory record for Healix
Listed by Nvision Biomedical Technologies, Inc, United States
FDA product code HWC
Device type Screw, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3040
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K182949
Record published 2019-04-30
Record revised 2026-07-28 (version 5)

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
Sizes Outer diameter 2 to 19.5 mm; length 10 to 60 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Healix
Catalogue number Size Status
CNH-20-12 Length 12 mm In distribution
SH-40-26 Outer Diameter 4.0 mm In distribution
CH-25-16 Outer Diameter 2.5 mm In distribution
SH-35-16 Outer Diameter 3.5 mm In distribution
CH-25-12 Outer Diameter 2.5 mm In distribution
CNH-20-10 Outer Diameter 2.0 mm In distribution
CNH-30-34 Length 34 mm In distribution
CNH-20-16 Length 16 mm In distribution
CH-45-46 Outer Diameter 4.5 mm In distribution
CNH-30-32 Length 32 mm In distribution
CNH-20-26 Length 26 mm In distribution
CNH-30-18 Length 18 mm In distribution
CNH-35-32 Length 32 mm In distribution
CNH-25-45H Outer Diameter 2.5 mm In distribution
CNH-45-50 Length 50 mm In distribution
CNH-40-30 Length 30 mm In distribution
SH-30-38 Outer Diameter 3.0 mm In distribution
SH-40-48 Outer Diameter 4.0 mm In distribution
CNH-30-40 Length 40 mm In distribution
CNH-25-16 Length 16 mm In distribution
SH-25-24 Outer Diameter 2.5 mm In distribution
CH-30-14 Outer Diameter 3.0 mm In distribution
CH-45-24 Outer Diameter 4.5 mm In distribution
CNH-35-38 Length 38 mm In distribution
SH-30-22 Outer Diameter 3.0 mm In distribution
CNH-30-26 Length 26 mm In distribution
SH-35-30 Outer Diameter 3.5 mm In distribution
CH-45-26 Outer Diameter 4.5 mm In distribution
CH-20-10 Length 10 mm In distribution
CNH-25-12 Length 12 mm In distribution
CH-20-12 Length 12 mm In distribution
SH-40-32 Outer Diameter 4.0 mm In distribution
CNH-40-44 Length 44 mm In distribution
CNH-45-30 Length 30 mm In distribution
CH-25-18 Outer Diameter 2.5 mm In distribution
CNH-30-36 Length 36 mm In distribution
CH-40-22 Outer Diameter 4.0 mm In distribution
CH-40-38 Outer Diameter 4.0 mm In distribution
SH-30-32 Length 32 mm In distribution
SH-25-14 Outer Diameter 2.5 mm In distribution
CH-20-14 Outer Diameter 2.0 mm In distribution
CH-45-56 Outer Diameter 4.5 mm In distribution
SH-25-12 Outer Diameter 2.5 mm In distribution
CNH-35-16 Length 16 mm In distribution
SH-20-24 Outer Diameter 2.0 mm In distribution
CNH-35-22 Length 22 mm In distribution
CH-40-26 Outer Diameter 4.0 mm In distribution
CH-45-30 Outer Diameter 4.5 mm In distribution
CH-45-60 Outer Diameter 4.5 mm In distribution
CNH-40-38 Length 38 mm In distribution
CH-25-28 Outer Diameter 2.5 mm In distribution
CNH-25-10 Length 10 mm In distribution
CNH-45-42 Length 42 mm In distribution
CNH-40-42 Length 42 mm In distribution
CH-25-30 Outer Diameter 2.5 mm In distribution
CNH-20-30 Length 30 mm In distribution
CNH-45-24 Length 24 mm In distribution
CNH-30-24 Length 24 mm In distribution
CH-35-30 Outer Diameter 3.5 mm In distribution
CH-40-30 Outer Diameter 4.0 mm In distribution
CNH-35-24 Length 24 mm In distribution
CH-40-34 Outer Diameter 4.0 mm In distribution
CH-45-42 Outer Diameter 4.5 mm In distribution
CNH-40-32 Length 32 mm In distribution
SH-20-16 Outer Diameter 2.0 mm In distribution
CH-40-36 Outer Diameter 4.0 mm In distribution
CNH-35-18 Length 18 mm In distribution
CNH-35-36 Length 36 mm In distribution
SH-25-26 Outer Diameter 2.5 mm In distribution
CH-35-34 Outer Diameter 3.5 mm In distribution
CH-45-32 Outer Diameter 4.5 mm In distribution
CNH-20-24 Length 24 mm In distribution
CH-45-48 Outer Diameter 4.5 mm In distribution
CNH-20-18 Length 18 mm In distribution
CNH-45-60 Length 60 mm In distribution
CNH-35-20 Length 20 mm In distribution
CNH-25-26 Length 26 mm In distribution
SH-20-30 Outer Diameter 2.0 mm In distribution
CH-30-40 Outer Diameter 3.0 mm In distribution
CH-35-16 Outer Diameter 3.5 mm In distribution
CNH-30-22 Length 22 mm In distribution
CNH-45-22 Length 22 mm In distribution
SH-35-36 Outer Diameter 3.5 mm In distribution
SH-40-40 Outer Diameter 4.0 mm In distribution
CNH-25-28 Length 28 mm In distribution
CNH-45-46 Length 46 mm In distribution
CNH-25-24 Length 24 mm In distribution
CNH-30-38 Length 38 mm In distribution
SH-20-28 Outer Diameter 2.0 mm In distribution
CH-45-22 Outer Diameter 4.5 mm In distribution
CH-30-34 Outer Diameter 3.0 mm In distribution
CNH-35-28 Length 28 mm In distribution
CH-30-24 Outer Diameter 3.0 mm In distribution
CH-45-20 Outer Diameter 4.5 mm In distribution
CNH-35-40 Length 40 mm In distribution
CNH-40-18 Length 18 mm In distribution
CH-40-40 Outer Diameter 4.0 mm In distribution
SH-35-32 Outer Diameter 3.5 mm In distribution
SH-40-34 Outer Diameter 4.0 mm In distribution
SH-40-50 Outer Diameter 4.0 mm In distribution
SH-25-18 Outer Diameter 2.5 mm In distribution
CH-35-20 Outer Diameter 3.5 mm In distribution
CH-35-28 Outer Diameter 3.5 mm In distribution
SH-20-18 Outer Diameter 2.0 mm In distribution
SH-35-26 Outer Diameter 3.5 mm In distribution
CNH-45-20 Length 20 mm In distribution
SH-30-28 Outer Diameter 3.0 mm In distribution
CH-25-24 Outer Diameter 2.5 mm In distribution
CSRW-WASH-225 Outer Diameter 5.09 mm In distribution
CNH-40-34 Length 34 mm In distribution
SH-25-28 Outer Diameter 2.5 mm In distribution
SH-35-18 Outer Diameter 3.5 mm In distribution
CH-40-24 Outer Diameter 4.0 mm In distribution
CSRW-WASH-665 Outer Diameter 15.73 mm In distribution
SH-40-36 Outer Diameter 4.0 mm In distribution
CH-45-54 Outer Diameter 4.5 mm In distribution
CH-40-50 Outer Diameter 4.0 mm In distribution
CNH-25-14 Length 14 mm In distribution
CNH-30-14 Length 14 mm In distribution
CNH-20-22 Length 22 mm In distribution
CH-25-20 Outer Diameter 2.5 mm In distribution
CH-30-20 Outer Diameter 3.0 mm In distribution
SH-30-20 Outer Diameter 3.0 mm In distribution
CNH-45-32 Length 32 mm In distribution
CSRW-WASH-555 Outer Diameter 13.87 mm In distribution
CH-40-42 Outer Diameter 4.0 mm In distribution
SH-40-18 Outer Diameter 4.0 mm In distribution
CH-45-50 Outer Diameter 4.5 mm In distribution
CNH-30-12 Length 12 mm In distribution
CH-30-26 Outer Diameter 3.0 mm In distribution
SH-40-46 Outer Diameter 4.0 mm In distribution
CH-30-28 Outer Diameter 3.0 mm In distribution
CH-25-14 Outer Diameter 2.5 mm In distribution
CH-45-52 Outer Diameter 4.5 mm In distribution
CNH-45-48 Length 48 mm In distribution
CNH-40-36 Length 36 mm In distribution
CH-35-24 Outer Diameter 3.5 mm In distribution
CH-35-38 Outer Diameter 3.5 mm In distribution
CNH-25-18 Length 18 mm In distribution
SH-25-16 Outer Diameter 2.5 mm In distribution
SH-30-16 Outer Diameter 3.0 mm In distribution
CH-30-32 Outer Diameter 3.0 mm In distribution
CH-40-28 Outer Diameter 4.0 mm In distribution
CH-40-18 Outer Diameter 4.0 mm In distribution
CNH-45-52 Length 52 mm In distribution
CNH-45-26 Length 26 mm In distribution
SH-25-10 Outer Diameter 2.5 mm In distribution
CH-20-20 Outer Diameter 2.0 mm In distribution
SH-20-26 Outer Diameter 2.0 mm In distribution
CH-40-48 Outer Diameter 4.0 mm In distribution
SH-20-20 Outer Diameter 2.0 mm In distribution
CNH-45-44 Length 44 mm In distribution
CH-40-46 Outer Diameter 4.0 mm In distribution
CH-35-26 Outer Diameter 3.5 mm In distribution
SH-25-22 Outer Diameter 2.5 mm In distribution
CNH-30-16 Length 16 mm In distribution
CH-40-32 Outer Diameter 4.0 mm In distribution
SH-30-34 Outer Diameter 3.0 mm In distribution
SH-35-22 Outer Diameter 3.5 mm In distribution
SH-30-30 Outer Diameter 3.0 mm In distribution
CH-20-24 Outer Diameter 2.0 mm In distribution
SH-20-14 Outer Diameter 2.0 mm In distribution
CH-30-12 Outer Diameter 3.0 mm In distribution
CNH-40-46 Length 46 mm In distribution
CH-25-26 Outer Diameter 2.5 mm In distribution
CH-20-26 Outer Diameter 2.0 mm In distribution
CNH-40-28 Length 28 mm In distribution
CNH-45-58 Length 58 mm In distribution
CNH-25-30 Length 30 mm In distribution
CH-20-16 Outer Diameter 2.0 mm In distribution
SH-40-20 Outer Diameter 4.0 mm In distribution
SH-20-10 Length 10 mm In distribution
SH-35-28 Outer Diameter 3.5 mm In distribution
SH-25-20 Outer Diameter 2.5 mm In distribution
CH-35-36 Outer Diameter 3.5 mm In distribution
CH-20-28 Outer Diameter 2.0 mm In distribution
SH-40-42 Outer Diameter 4.0 mm In distribution
SH-35-20 Outer Diameter 3.5 mm In distribution
CH-45-40 Outer Diameter 4.5 mm In distribution
CNH-25-40H Outer Diameter 2.5 mm In distribution
CNH-40-40 Length 40 mm In distribution
SH-20-22 Outer Diameter 2.0 mm In distribution
CNH-35-34 Length 34 mm In distribution
SH-30-24 Outer Diameter 3.0 mm In distribution
CH-45-38 Outer Diameter 4.5 mm In distribution
SH-40-22 Length 22 mm In distribution
CNH-45-28 Length 28 mm In distribution
CNH-30-20 Length 20 mm In distribution
CNH-30-10 Length 10 mm In distribution
CH-25-22 Outer Diameter 2.5 mm In distribution
SH-30-10 Outer Diameter 3.0 mm In distribution
CH-30-16 Outer Diameter 3.0 mm In distribution
CNH-45-36 Length 36 mm In distribution
CH-20-22 Outer Diameter 2.0 mm In distribution
CH-30-38 Outer Diameter 3.0 mm In distribution
CNH-45-56 Length 56 mm In distribution
CNH-20-45H Outer Diameter 2.0 mm In distribution
SH-30-14 Outer Diameter 3.0 mm In distribution
SH-35-34 Outer Diameter 3.5 mm In distribution
CNH-40-50 Length 50 mm In distribution
CH-40-44 Outer Diameter 4.0 mm In distribution
CH-45-36 Outer Diameter 4.5 mm In distribution
SH-30-26 Outer Diameter 3.0 mm In distribution
SH-30-40 Outer Diameter 3.0 mm In distribution
CNH-30-30 Length 30 mm In distribution
SH-40-30 Outer Diameter 4.0 mm In distribution
SH-35-38 Outer Diameter 3.5 mm In distribution
CH-45-34 Outer Diameter 4.5 mm In distribution
CH-35-32 Outer Diameter 3.5 mm In distribution
CNH-20-40H Outer Diameter 2.0 mm In distribution
CNH-40-22 Length 22 mm In distribution
SH-20-12 Outer Diameter 2.0 mm In distribution
CH-25-10 Outer Diameter 2.5 mm In distribution
CNH-20-20 Length 20 mm In distribution
CH-45-44 Outer Diameter 4.5 mm In distribution
SH-40-38 Outer Diameter 4.0 mm In distribution
SH-40-28 Outer Diameter 4.0 mm In distribution
CH-40-20 Outer Diameter 4.0 mm In distribution
CNH-30-28 Length 28 mm In distribution
CSRW-WASH-445 Outer Diameter 11.82 mm In distribution
SH-30-18 Outer Diameter 3.0 mm In distribution
CH-30-30 Outer Diameter 3.0 mm In distribution
CSRW-WASH-335 Outer Diameter 7.64 mm In distribution
CNH-40-20 Length 20 mm In distribution
CNH-20-35H Outer Diameter 2.0 mm In distribution
CSRW-WASH-775 Outer Diameter 19.50 mm In distribution
CH-20-18 Outer Diameter 2.0 mm In distribution
SH-35-40 Outer Diameter 3.5 mm In distribution
CH-30-10 Outer Diameter 3.0 mm In distribution
SH-30-36 Outer Diameter 3.0 mm In distribution
SH-35-24 Outer Diameter 3.5 mm In distribution
CH-35-40 Outer Diameter 3.5 mm In distribution
CNH-35-26 Length 26 mm In distribution
SH-40-24 Outer Diameter 4.0 mm In distribution
CH-35-22 Outer Diameter 3.5 mm In distribution
CH-30-22 Outer Diameter 3.0 mm In distribution
CNH-45-34 Length 34 mm In distribution
CNH-25-22 Length 22 mm In distribution
CNH-25-20 Length 20 mm In distribution
CNH-45-54 Length 54 mm In distribution
SH-40-44 Outer Diameter 4.0 mm In distribution
CNH-20-28 Length 28 mm In distribution
CH-20-30 Outer Diameter 2.0 mm In distribution
SH-25-30 Outer Diameter 2.5 mm In distribution
CH-30-18 Outer Diameter 3.0 mm In distribution
CH-35-18 Outer Diameter 3.5 mm In distribution
CH-45-28 Outer Diameter 4.5 mm In distribution
CH-30-36 Outer Diameter 3.0 mm In distribution
SH-30-12 Outer Diameter 3.0 mm In distribution
CNH-40-24 Length 24 mm In distribution

Showing 250 of 257 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Screw, Fixation, Bone Synthes Gmbh 3,975
Aptus Medartis Inc. 3,623
Acumed Acumed LLC 3,187
Arthrex® Arthrex, Inc. 2,781
OsteoMed Osteomed 2,764
Screw, Fixation, Bone AAP Implantate AG 2,176
Screw, Fixation, Bone Zimmer, Inc. 1,993
Arix System Bone Screw Jeil Medical Corporation 1,875
Cannulated Screw System + Tyber Medical 1,814
Cannulated Compression Headless Screw Tyber Medical 1,621
Microware Bone Plates and Bone Screws Microware Precision Co., Ltd. 1,601
Anthem Globus Medical, Inc. 1,538

Showing 12 of 5,775. All products under Screw, Fixation, Bone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K250613 2025-04-02
K242896 2025-02-05
K231453 2024-02-16
K213421 2021-11-19
K201850 2020-08-04
K200914 2020-05-05
K183055 2019-02-19
K182949 2018-12-04

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