Arthrex®
3.8x55mm Headless FibuLock® Scrw, SS, STR
17manufacturers in China registered for this device type
665catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| 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 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Record published | 2024-01-21 |
| Record revised | 2025-02-06 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-9096R-11-36 | In distribution | |
| AR-9096R-10-40 | In distribution | |
| AR-9094-0120 | In distribution | |
| AR-9096R-12-34 | In distribution | |
| AR-9094-11-4225L | In distribution | |
| AR-9094ES-11-3325R | In distribution | |
| AR-9094ES-11-4225L | In distribution | |
| AR-9096R-13-28 | In distribution | |
| AR-9096A-13-32R | In distribution | |
| AR-9098-09-420 | In distribution | |
| AR-9096R-11-42 | In distribution | |
| AR-9096A-10-38L | In distribution | |
| AR-9096R-12-32 | In distribution | |
| AR-9096FT-65-100 | In distribution | |
| AR-9096A-09-46L | In distribution | |
| AR-9093-50-038 | In distribution | |
| AR-9096CA-65-35 | In distribution | |
| AR-9098-12-330 | In distribution | |
| AR-9094-11-3925L | In distribution | |
| AR-9094ES-11-3625R | In distribution | |
| AR-9090-14EC | In distribution | |
| AR-9050-35 | In distribution | |
| AR-9094-0080 | In distribution | |
| AR-9096R-11-40 | In distribution | |
| AR-9098-12-345 | In distribution | |
| AR-9098-08-270 | In distribution | |
| AR-9096A-11-42R | In distribution | |
| AR-9096CA-65-120 | In distribution | |
| AR-9096FT-65-120 | In distribution | |
| AR-9093-50-120 | In distribution | |
| AR-9094-095 | In distribution | |
| AR-9094AR-065 | In distribution | |
| AR-9094ES-11-3325L | In distribution | |
| AR-9098-11-360 | In distribution | |
| AR-9050-115 | In distribution | |
| AR-9094AR-080 | In distribution | |
| AR-9090S | In distribution | |
| AR-9094AR-075 | In distribution | |
| AR-9094ES-10-3330L | In distribution | |
| AR-9094ES-10-3025L | In distribution | |
| AR-9094ES-10-3930L | In distribution | |
| AR-9096A-09-34L | In distribution | |
| AR-9094-0090 | In distribution | |
| AR-9096A-13-36L | In distribution | |
| AR-8973L-38-130 | In distribution | |
| AR-8827H-38 | In distribution | |
| AR-9096B | In distribution | |
| AR-9050-120 | In distribution | |
| AR-8973R-38-180 | In distribution | |
| AR-9094ES-12-3030R | In distribution | |
| AR-9096NW | In distribution | |
| AR-8838H-60 | In distribution | |
| AR-9094-110L | In distribution | |
| AR-9050-40 | In distribution | |
| AR-9096R-10-26 | In distribution | |
| AR-9094ES-12-4230L | In distribution | |
| AR-9094-12-3930R | In distribution | |
| AR-9094-0095 | In distribution | |
| AR-9096FT-65-090 | In distribution | |
| AR-9098-42-042 | In distribution | |
| AR-9096A-11-46R | In distribution | |
| AR-9093-50-115 | In distribution | |
| AR-9096A-09-38R | In distribution | |
| AR-9096PT-60-100 | In distribution | |
| AR-9096FT-65-075 | In distribution | |
| AR-9096A-13-46R | In distribution | |
| AR-9050-75H | In distribution | |
| AR-9093-50-060 | In distribution | |
| AR-9098-08-390 | In distribution | |
| AR-9094-085 | In distribution | |
| AR-9050-24 | In distribution | |
| AR-9096CA-65-110 | In distribution | |
| AR-9050-95H | In distribution | |
| AR-9096S-12-22 | In distribution | |
| AR-9096R-12-36 | In distribution | |
| AR-9050-20 | In distribution | |
| AR-9050-110 | In distribution | |
| AR-8974-01L | In distribution | |
| AR-9094-1105 | In distribution | |
| AR-9094-12-3330R | In distribution | |
| AR-9096A-14-30R | In distribution | |
| AR-9094-13-2030 | In distribution | |
| AR-9096A-12-36R | In distribution | |
| AR-9098-11-390 | In distribution | |
| AR-9094ES-10-4530L | In distribution | |
| AR-9094-10-3325R | In distribution | |
| AR-9094ES-10-4230L | In distribution | |
| AR-9096A-12-40L | In distribution | |
| AR-9098-42-047 | In distribution | |
| AR-9096CA-65-80 | In distribution | |
| AR-9094-11-4530R | In distribution | |
| AR-9094-10-3930R | In distribution | |
| AR-9098-10-285 | In distribution | |
| AR-9094ES-11-3025L | In distribution | |
| AR-9050-30 | In distribution | |
| AR-9094ES-10-3330R | In distribution | |
| AR-8838H-55S | In distribution | |
| AR-9050-50H | In distribution | |
| AR-9094AR-070 | In distribution | |
| AR-9094-095L | In distribution | |
| AR-9098-10-390 | In distribution | |
| AR-9050-42 | In distribution | |
| AR-9098-08-300 | In distribution | |
| AR-9098-09-285 | In distribution | |
| AR-9098-12-405 | In distribution | |
| AR-9093-50-022 | In distribution | |
| AR-9098-13-270 | In distribution | |
| AR-9093-50-034 | In distribution | |
| AR-9091-02 | In distribution | |
| AR-9094ES-14-3330R | In distribution | |
| AR-9093-50-032 | In distribution | |
| AR-9094ES-10-3625L | In distribution | |
| AR-9094-125L | In distribution | |
| AR-9094-090L | In distribution | |
| AR-9096A-14-38R | In distribution | |
| AR-9094ES-11-4230L | In distribution | |
| AR-9094-105 | In distribution | |
| AR-8838H-35S | In distribution | |
| AR-9096A-10-46L | In distribution | |
| AR-9094-11-3330R | In distribution | |
| AR-9094-100 | In distribution | |
| AR-9096A-14-46L | In distribution | |
| AR-9096R-12-26 | In distribution | |
| AR-9096A-10-36R | In distribution | |
| AR-9098-10-300 | In distribution | |
| AR-9093-50-100 | In distribution | |
| AR-9096PT-60-120 | In distribution | |
| AR-9096S-10-22 | In distribution | |
| AR-9094-10-3930L | In distribution | |
| AR-9098-08-345 | In distribution | |
| AR-9096A-10-42R | In distribution | |
| AR-9091-01A | In distribution | |
| AR-9094ES-12-4230R | In distribution | |
| AR-9096A-12-46R | In distribution | |
| AR-9090-13EC | In distribution | |
| AR-9096A-10-32L | In distribution | |
| AR-9094ES-10-4525L | In distribution | |
| AR-9094ES-12-3630L | In distribution | |
| AR-8973EC | In distribution | |
| AR-9093-50-044 | In distribution | |
| AR-9093-50-105 | In distribution | |
| AR-9094ES-10-3630L | In distribution | |
| AR-9094ES-12-4525L | In distribution | |
| AR-9094-10-4525R | In distribution | |
| AR-9098-10-330 | In distribution | |
| AR-9096A-14-40R | In distribution | |
| AR-9094ES-12-3625R | In distribution | |
| AR-9050-80H | In distribution | |
| AR-9096A-13-38R | In distribution | |
| AR-9098-12-375 | In distribution | |
| AR-9094ES-10-3325L | In distribution | |
| AR-9094ES-12-4530L | In distribution | |
| AR-9094-10-3925L | In distribution | |
| AR-9050-65H | In distribution | |
| AR-9093-50-110 | In distribution | |
| AR-9094-1075 | In distribution | |
| AR-8974R-30-130 | In distribution | |
| AR-9096FT-65-095 | In distribution | |
| AR-9094-10-4225R | In distribution | |
| AR-9096PT-60-95 | In distribution | |
| AR-9094ES-10-3325R | In distribution | |
| AR-9096A-10-42L | In distribution | |
| AR-9098-12-360 | In distribution | |
| AR-9096A-09-40R | In distribution | |
| AR-9096R-10-36 | In distribution | |
| AR-9096A-11-44L | In distribution | |
| AR-9096R-13-38 | In distribution | |
| AR-9094CP-01 | In distribution | |
| AR-9098-42-040 | In distribution | |
| AR-9096R-12-30 | In distribution | |
| AR-9091-01 | In distribution | |
| AR-8838H-20 | In distribution | |
| AR-9094ES-11-3625L | In distribution | |
| AR-9096A-10-38R | In distribution | |
| AR-9096A-12-34R | In distribution | |
| AR-9096PT-60-30 | In distribution | |
| AR-9094-090 | In distribution | |
| AR-9096FT-65-065 | In distribution | |
| AR-9096A-12-44R | In distribution | |
| AR-9094-12-3030R | In distribution | |
| AR-9096A-11-40L | In distribution | |
| AR-9096A-13-36R | In distribution | |
| AR-8838H-20S | In distribution | |
| AR-9098-11-330 | In distribution | |
| AR-9090-11S | In distribution | |
| AR-9094-1120 | In distribution | |
| AR-9090-03S | In distribution | |
| AR-9096FT-65-035 | In distribution | |
| AR-9050-38 | In distribution | |
| AR-9096A-09-34R | In distribution | |
| AR-9094ES-11-3330R | In distribution | |
| AR-9093-50-070 | In distribution | |
| AR-9094-11-3625L | In distribution | |
| AR-9094-085L | In distribution | |
| AR-9094-11-3930L | In distribution | |
| AR-9094-080 | In distribution | |
| AR-9096A-11-38L | In distribution | |
| AR-9096A-13-34R | In distribution | |
| AR-9094AR-110 | In distribution | |
| AR-9098-10-375 | In distribution | |
| AR-9094ES-10-4530R | In distribution | |
| AR-9096A-09-30R | In distribution | |
| AR-9096A-14-36L | In distribution | |
| AR-9094ES-12-3925R | In distribution | |
| AR-9096A-09-36R | In distribution | |
| AR-9094-11-4525R | In distribution | |
| AR-9098-42-035 | In distribution | |
| AR-9094-10-4530R | In distribution | |
| AR-9094-1115 | In distribution | |
| AR-9096A-11-34R | In distribution | |
| AR-9096CP-A | In distribution | |
| AR-8827H-14S | In distribution | |
| AR-8838H-40 | In distribution | |
| AR-9096A-12-46L | In distribution | |
| AR-9094ES-11-3030L | In distribution | |
| AR-9090-05S | In distribution | |
| AR-9094-10-3030R | In distribution | |
| AR-9094ES-12-3325R | In distribution | |
| AR-9094ES-10-3925L | In distribution | |
| AR-9094ES-11-4230R | In distribution | |
| AR-9094ES-10-3625R | In distribution | |
| AR-9096CA-65-45 | In distribution | |
| AR-9098-09-405 | In distribution | |
| AR-9094-1090 | In distribution | |
| AR-9094ES-14-3030R | In distribution | |
| AR-9094AR-095 | In distribution | |
| AR-9050-90H | In distribution | |
| AR-9096A-13-42R | In distribution | |
| AR-9091C-17S | In distribution | |
| AR-9094-11-3025R | In distribution | |
| AR-9096A-11-46L | In distribution | |
| AR-9096R-10-38 | In distribution | |
| AR-9094ES-14-3630L | In distribution | |
| AR-9096R-12-38 | In distribution | |
| AR-9091-01B | In distribution | |
| AR-9096CA-65-30 | In distribution | |
| AR-9096A-12-42L | In distribution | |
| AR-9096A-13-40L | In distribution | |
| AR-9096A-09-40L | In distribution | |
| AR-9096R-10-34 | In distribution | |
| AR-9096CA-10 | In distribution | |
| AR-9050-65 | In distribution | |
| AR-8973R-30-180 | In distribution | |
| AR-8974R-38-180 | In distribution | |
| AR-9094-11-3325R | In distribution | |
| AR-9096R-13-40 | In distribution | |
| AR-9098-11-300 | In distribution | |
| AR-9094-11-3630L | In distribution | |
| AR-9090-07S | In distribution | |
| AR-9094-10-3330R | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
| Precice® Bone Transport System | NuVasive Specialized Orthopedics, Inc. | 546 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252016 | 2026-03-20 |
| K252196 | 2026-03-05 |
| K243890 | 2025-01-13 |
| K230257 | 2023-07-17 |
| K221031 | 2022-12-20 |
| K173656 | 2018-07-26 |
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.