Orthofix
Fitbone Transport Lengthening Trial Nail TLN 1180-F-20-370 Sterile
17manufacturers in China registered for this device type
721catalogue numbers in this listing
14510(k) clearances naming this product code
1recall
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 | Orthofix SRL, Italy |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K233867 |
| Record published | 2024-07-05 |
| Record revised | 2025-10-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 3 to 133 mm; length 20 to 490 mm; outer diameter 4 to 13 µm; length 310 to 490 µm |
| Distribution end date | 2024-10-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 300 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Length 330 mm | In distribution |
| 1 | Length 310 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Outer Diameter 4 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Length 310 mm | In distribution |
| 1 | Length 350 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Length 330 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 470 mm | In distribution |
| 1 | Length 330 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 310 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Length 310 mm | In distribution |
| 1 | Length 290 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 350 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Length 330 mm | In distribution |
| 1 | Length 350 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 350 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 350 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 330 mm | In distribution |
| 1 | Length 300 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 290 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Length 290 mm | In distribution |
| 1 | Length 330 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 350 mm | In distribution |
| 1 | Length 310 µm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 310 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Length 350 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 350 mm | In distribution |
| 1 | Length 350 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 290 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 330 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 490 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 330 mm | In distribution |
| 1 | Length 390 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 470 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Length 330 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 330 mm | In distribution |
| 1 | Length 290 mm | In distribution |
| 1 | Length 310 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 350 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Outer Diameter 4.0 mm | In distribution |
| 1 | Length 430 mm | In distribution |
| 1 | Length 370 mm | In distribution |
| 1 | Length 410 mm | In distribution |
| 1 | Length 430 mm | 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 |
| 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 |
| 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 |
|---|---|
| K260146 | 2026-05-19 |
| K253991 | 2026-05-08 |
| K250112 | 2025-04-10 |
| K233867 | 2024-06-18 |
| K232648 | 2024-05-03 |
| K232169 | 2024-03-22 |
| K172699 | 2018-04-23 |
| K173458 | 2017-12-07 |
| K161466 | 2017-01-24 |
| K141571 | 2014-11-12 |
| K053261 | 2005-12-12 |
| K031219 | 2003-05-28 |
| K973944 | 1997-12-19 |
| K961027 | 1996-05-08 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Orthofix SRL | 510(k) number | 2024-09-24 | Class II | Use error | Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced. | 2 units |
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.