Flow-Screw™

Flow-Screw is a cannulated bone screw that combines mechanical fixation with a pathway for injectable bone void filler. It is intended for temporary fixation and stabilization in bone…

Registry build 21.09.26

Flow-Screw is a cannulated bone screw that combines mechanical fixation with a pathway for injectable bone void filler. It is intended for temporary fixation and stabilization in bone fractures and reconstruction.

Openings along the screw connect its central channel to the surrounding site, allowing filler to be delivered through the implant. The threaded portion engages bone and supplies the screw’s fixation function.

Listed Item

SCREW, CANNULATED, (6.5 MM x 115 MM), PARTIALLY THREADED SHORT

Thread and Material Options

The range includes fully and partially threaded designs in different lengths. Implants are made from titanium alloy or implant-grade stainless steel, so thread pattern, length and material are separate configuration choices within the family.

31manufacturers in China registered for this device type
889catalogue numbers in this listing
1510(k) clearance

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 Flow-Screw™
Listed by Flow-Fx, LLC, United States
FDA product code HWC
Device type Screw, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3040
510(k) K142776
Record published 2017-12-04
Record revised 2024-02-19 (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
Over the counter Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Flow-Screw™
Catalogue number Size Status
45-0032 In distribution
102-55-0054T In distribution
45-0020 In distribution
102-45-0042T In distribution
102-65-2075T In distribution
55-1085 In distribution
102-65-2095T In distribution
73-0085 In distribution
102-55-0040T In distribution
55-2090 In distribution
102-55-2020T In distribution
45-0014 In distribution
102-65-0115T In distribution
73-0110 In distribution
102-65-1095T In distribution
55-0042 In distribution
73-1070 In distribution
73-1135 In distribution
102-35-0050T In distribution
65-0060 In distribution
55-0040 In distribution
102-45-2040T In distribution
65-0125 In distribution
35-2022 In distribution
65-0040 In distribution
45-2042 In distribution
65-1125 In distribution
102-73-1045T In distribution
55-0065 In distribution
73-0055 In distribution
102-73-2130T In distribution
55-0054 In distribution
102-55-2044T In distribution
102-45-2056T In distribution
102-65-1060T In distribution
102-73-2090T In distribution
102-65-0130T In distribution
55-1065 In distribution
55-1052 In distribution
55-2026 In distribution
55-2115 In distribution
73-1125 In distribution
102-35-2024T In distribution
55-2040 In distribution
102-65-2060T In distribution
73-0135 In distribution
73-1075 In distribution
102-73-2070T In distribution
35-2040 In distribution
55-2046 In distribution
65-0145 In distribution
102-55-2115T In distribution
102-65-0125T In distribution
102-55-0120T In distribution
102-35-2050T In distribution
73-0125 In distribution
45-0042 In distribution
65-0095 In distribution
102-65-0090T In distribution
102-35-2046T In distribution
55-0110 In distribution
55-0030 In distribution
65-1120 In distribution
65-0080 In distribution
73-2060 In distribution
65-1065 In distribution
73-2025 In distribution
45-2010 In distribution
55-1105 In distribution
102-45-0032T In distribution
102-45-0028T In distribution
45-0030 In distribution
102-65-1065T In distribution
45-2028 In distribution
73-0080 In distribution
102-65-2050T In distribution
102-55-0075T In distribution
102-55-2022T In distribution
45-0030 In distribution
35-2018 In distribution
65-2040 In distribution
55-0032 In distribution
45-0056 In distribution
73-2030 In distribution
102-73-2115T In distribution
55-0046 In distribution
102-35-2020T In distribution
102-45-0030T In distribution
73-2035 In distribution
102-35-0032T In distribution
55-1060 In distribution
55-2032 In distribution
73-1050 In distribution
102-55-1058T In distribution
102-73-1060T In distribution
102-55-1115T In distribution
55-1120 In distribution
73-0090 In distribution
102-65-0040T In distribution
102-55-1052T In distribution
35-2036 In distribution
65-1060 In distribution
73-2060 In distribution
45-2052 In distribution
73-0125 In distribution
35-2016 In distribution
73-1100 In distribution
73-0065 In distribution
55-0065 In distribution
65-2055 In distribution
102-73-2135T In distribution
45-2058 In distribution
102-55-2024T In distribution
102-73-1130T In distribution
45-0032 In distribution
102-35-0028T In distribution
102-35-2032T In distribution
55-0110 In distribution
35-0024 In distribution
102-65-0110T In distribution
102-65-1050T In distribution
55-2034 In distribution
102-73-2125T In distribution
102-65-2065T In distribution
102-73-0105T In distribution
65-2060 In distribution
45-2034 In distribution
102-35-0040T In distribution
45-2060 In distribution
65-0105 In distribution
65-1065 In distribution
102-45-0022T In distribution
102-65-0135T In distribution
55-2120 In distribution
102-73-2120T In distribution
102-45-2026T In distribution
55-2042 In distribution
45-2024 In distribution
73-2150 In distribution
102-35-0030T In distribution
102-35-0014T In distribution
73-1105 In distribution
102-73-1140T In distribution
102-73-1025T In distribution
102-73-1115T In distribution
102-65-0145T In distribution
102-73-1020T In distribution
102-73-0040T In distribution
102-45-2022T In distribution
102-65-0035T In distribution
102-45-0056T In distribution
102-55-0085T In distribution
102-65-2105T In distribution
55-1060 In distribution
102-35-2034T In distribution
102-73-0050T In distribution
55-2048 In distribution
102-73-0055T In distribution
45-0044 In distribution
73-1150 In distribution
73-1110 In distribution
65-1120 In distribution
55-2040 In distribution
102-35-2016T In distribution
102-65-2150T In distribution
73-1055 In distribution
55-0120 In distribution
55-0095 In distribution
73-0145 In distribution
55-2075 In distribution
65-0085 In distribution
102-73-0020T In distribution
102-45-2020T In distribution
102-55-0030T In distribution
73-0140 In distribution
73-1120 In distribution
102-55-2046T In distribution
65-1060 In distribution
45-2036 In distribution
102-65-0150T In distribution
102-73-1150T In distribution
102-73-2055T In distribution
102-35-0022T In distribution
102-55-1110T In distribution
102-65-1055T In distribution
102-35-2010T In distribution
55-2095 In distribution
55-0048 In distribution
102-35-0036T In distribution
55-0038 In distribution
55-0105 In distribution
45-2030 In distribution
65-1145 In distribution
55-1085 In distribution
55-0090 In distribution
73-2045 In distribution
102-45-0016T In distribution
55-0052 In distribution
55-1090 In distribution
55-2054 In distribution
65-0065 In distribution
65-0150 In distribution
73-1150 In distribution
102-55-0050T In distribution
55-2115 In distribution
102-55-0042T In distribution
45-0044 In distribution
73-2040 In distribution
45-2030 In distribution
55-1080 In distribution
102-55-2054T In distribution
65-1110 In distribution
55-1054 In distribution
73-0145 In distribution
55-1080 In distribution
55-2058 In distribution
45-2048 In distribution
73-0050 In distribution
102-45-2054T In distribution
45-2060 In distribution
55-0070 In distribution
55-1065 In distribution
73-0075 In distribution
73-0140 In distribution
55-2070 In distribution
35-0020 In distribution
65-1085 In distribution
102-35-2042T In distribution
55-2034 In distribution
45-2040 In distribution
55-2095 In distribution
35-0014 In distribution
102-35-0024T In distribution
65-0115 In distribution
102-35-0016T In distribution
55-1044 In distribution
65-0115 In distribution
102-73-0135T In distribution
55-1058 In distribution
102-35-0012T In distribution
45-2048 In distribution
45-0050 In distribution
45-0040 In distribution
35-0032 In distribution
55-1110 In distribution
102-30 In distribution
102-65-2085T In distribution
45-0036 In distribution
45-0014 In distribution
102-55-1048T In distribution

Showing 250 of 300 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
K142776 2015-03-23

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