Pro-X1
Ø2.5mm x 1000mm Long Guidewire (Ø3.9mm ball tip diam.)
17manufacturers in China registered for this device type
60catalogue numbers in this listing
1510(k) clearance
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 | X-Bolt Orthopedics, Ireland |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2024-08-27 |
| Record revised | 2025-02-06 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 30 to 1000 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XBT105085 | Length 85 mm | In distribution |
| XNI-016 | In distribution | |
| XNI-005 | In distribution | |
| XBT105125 | Length 125 mm | In distribution |
| XNI-030 | In distribution | |
| XBT105115 | Length 115 mm | In distribution |
| XBT032001 | Length 390 mm | In distribution |
| XBT050050 | Length 50 mm | In distribution |
| XBT110400R | Length 400 mm | In distribution |
| XBT110375R | Length 375 mm | In distribution |
| XNI-015 | In distribution | |
| XBT040305 | Length 305 mm | In distribution |
| XNI-020 | In distribution | |
| XBT105080 | Length 80 mm | In distribution |
| XBT110425L | Length 425 mm | In distribution |
| XNI-025 | In distribution | |
| XBT105090 | Length 90 mm | In distribution |
| XNI-006 | In distribution | |
| XBT105100 | Length 100 mm | In distribution |
| XNI-023 | In distribution | |
| XNI-022 | In distribution | |
| XNI-014 | In distribution | |
| XBT050030 | Length 30 mm | In distribution |
| XBT110350L | Length 350 mm | In distribution |
| XNI-008 | In distribution | |
| XNI-021 | In distribution | |
| XNI-004 | In distribution | |
| XNI-100-X | In distribution | |
| XBT050035 | Length 35 mm | In distribution |
| XBT110375L | Length 375 mm | In distribution |
| XBT105120 | Length 120 mm | In distribution |
| XBT110425R | Length 425 mm | In distribution |
| XBT105110 | In distribution | |
| XBT050045 | Length 45 mm | In distribution |
| XBT050055 | Length 55 mm | In distribution |
| XBT110195 | Length 195 mm | In distribution |
| XNI-018 | In distribution | |
| XBT040150 | Length 150 mm | In distribution |
| XBT105105 | Length 105 mm | In distribution |
| XNI-024 | In distribution | |
| XNI-012 | In distribution | |
| XBT110350R | Length 350 mm | In distribution |
| XNI-003 | In distribution | |
| XBT105095 | Length 95 mm | In distribution |
| XNI-200-Y | In distribution | |
| XBT024900 | Length 1000 mm | In distribution |
| XNI-011 | In distribution | |
| XBT110300R | Length 300 mm | In distribution |
| XBT050040 | Length 40 mm | In distribution |
| XNI-028 | In distribution | |
| XNI-002 | In distribution | |
| XNI-019 | In distribution | |
| XBT110325R | In distribution | |
| XNI-032 | In distribution | |
| XNI-009 | In distribution | |
| XBT110300L | Length 300 mm | In distribution |
| XBT110325L | Length 325 mm | In distribution |
| XBT110400L | Length 400 mm | In distribution |
| XNI-007 | In distribution | |
| XNI-017 | In distribution |
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 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221621 | 2023-03-06 |
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.