Rod, Fixation, Intramedullary and Accessories
Femur Reconstruction Nail, Right Ø13x420 mm
17manufacturers in China registered for this device type
230catalogue 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 | TDM Co., Ltd., South Korea |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Manufacturer |
| 510(k) | K230071 |
| Record published | 2025-01-16 |
| Record revised | 2025-02-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 503-39400 | Ø9×400 mm | In distribution |
| 503-33420 | Ø13×420 mm | In distribution |
| 508-30200 | In distribution | |
| 507-32509 | In distribution | |
| 502-08345 | In distribution | |
| 503-22320 | Ø12×320 mm | In distribution |
| 503-20400 | Ø10×400 mm | In distribution |
| 507-62538 | In distribution | |
| 502-09375 | In distribution | |
| 507-32510 | In distribution | |
| 533-20310 | In distribution | |
| 508-30305 | In distribution | |
| 507-33012 | In distribution | |
| 509-09220 | In distribution | |
| 533-20315 | In distribution | |
| 502-09405 | In distribution | |
| 502-13405 | In distribution | |
| 502-09315 | In distribution | |
| 503-23420 | Ø13×420 mm | In distribution |
| 503-30340 | Ø10×340 mm | In distribution |
| 502-13285 | In distribution | |
| 507-23009 | In distribution | |
| 502-10315 | In distribution | |
| 503-33380 | Ø13×380 mm | In distribution |
| 503-31340 | Ø11×340 mm | In distribution |
| 503-33400 | Ø13×400 mm | In distribution |
| 503-22340 | Ø12×340 mm | In distribution |
| 509-02200 | In distribution | |
| 507-42534 | In distribution | |
| 502-12360 | In distribution | |
| 502-09285 | In distribution | |
| 507-52540 | In distribution | |
| 508-30010 | In distribution | |
| 502-09255 | In distribution | |
| 509-07220 | In distribution | |
| 503-30320 | Ø10×320 mm | In distribution |
| 533-20305 | In distribution | |
| 503-21400 | Ø11×400 mm | In distribution |
| 507-33009 | In distribution | |
| 502-08270 | In distribution | |
| 507-92534 | In distribution | |
| 507-82532 | In distribution | |
| 507-92532 | In distribution | |
| 507-72534 | In distribution | |
| 503-31320 | Ø11×320 mm | In distribution |
| 503-21380 | Ø11×380 mm | In distribution |
| 502-12285 | In distribution | |
| 502-13390 | In distribution | |
| 502-10420 | In distribution | |
| 503-22420 | Ø12×420 mm | In distribution |
| 507-22512 | In distribution | |
| 509-07240 | In distribution | |
| 502-08255 | In distribution | |
| 502-13420 | In distribution | |
| 507-22511 | In distribution | |
| 502-10345 | In distribution | |
| 507-23010 | In distribution | |
| 502-11345 | In distribution | |
| 507-33010 | In distribution | |
| 502-09300 | In distribution | |
| 509-09240 | In distribution | |
| 530-01015 | In distribution | |
| 533-20301 | In distribution | |
| 509-08240 | In distribution | |
| 508-30020 | In distribution | |
| 508-30315 | In distribution | |
| 508-30320 | In distribution | |
| 502-08405 | In distribution | |
| 502-13330 | In distribution | |
| 507-52536 | In distribution | |
| 503-31400 | Ø11×400 mm | In distribution |
| 508-30015 | In distribution | |
| 502-11360 | In distribution | |
| 508-30310 | In distribution | |
| 502-13315 | In distribution | |
| 502-11300 | In distribution | |
| 502-11405 | In distribution | |
| 503-32320 | Ø12×320 mm | In distribution |
| 507-82542 | In distribution | |
| 503-23360 | Ø13×360 mm | In distribution |
| 503-33360 | Ø13×360 mm | In distribution |
| 507-33011 | In distribution | |
| 502-12420 | In distribution | |
| 503-23380 | Ø13×380 mm | In distribution |
| 509-08220 | In distribution | |
| 509-09260 | In distribution | |
| 503-22380 | Ø12×380 mm | In distribution |
| 503-29400 | Ø9×400 mm | In distribution |
| 530-00010 | In distribution | |
| 507-23011 | In distribution | |
| 530-01010 | In distribution | |
| 507-82538 | In distribution | |
| 503-39360 | Ø9×360 mm | In distribution |
| 503-31360 | Ø11×360 mm | In distribution |
| 502-09390 | In distribution | |
| 502-10255 | In distribution | |
| 507-12509 | In distribution | |
| 503-32420 | Ø12×420 mm | In distribution |
| 508-30101 | In distribution | |
| 502-13375 | In distribution | |
| 503-20380 | Ø10×380 mm | In distribution |
| 503-23400 | Ø13×400 mm | In distribution |
| 502-08360 | In distribution | |
| 507-42542 | In distribution | |
| 502-10360 | In distribution | |
| 503-30360 | Ø10×360 mm | In distribution |
| 509-08300 | In distribution | |
| 502-08315 | In distribution | |
| 530-01005 | In distribution | |
| 507-12512 | In distribution | |
| 502-11270 | In distribution | |
| 502-11390 | In distribution | |
| 507-62534 | In distribution | |
| 503-29320 | Ø9×320 mm | In distribution |
| 503-39380 | Ø9×380 mm | In distribution |
| 503-21360 | Ø11×360 mm | In distribution |
| 503-22400 | Ø12×400 mm | In distribution |
| 503-20320 | Ø10×320 mm | In distribution |
| 509-07260 | In distribution | |
| 502-09345 | In distribution | |
| 508-30300 | In distribution | |
| 502-12375 | In distribution | |
| 508-31100 | In distribution | |
| 502-08330 | In distribution | |
| 502-12405 | In distribution | |
| 502-12255 | In distribution | |
| 507-12511 | In distribution | |
| 502-10300 | In distribution | |
| 507-32511 | In distribution | |
| 530-01000 | In distribution | |
| 509-07300 | In distribution | |
| 503-30400 | Ø10×400 mm | In distribution |
| 502-13345 | In distribution | |
| 503-32380 | Ø12×380 mm | In distribution |
| 509-02160 | In distribution | |
| 507-13009 | In distribution | |
| 507-52538 | In distribution | |
| 508-30005 | In distribution | |
| 502-08375 | In distribution | |
| 507-42538 | In distribution | |
| 502-09420 | In distribution | |
| 502-11255 | In distribution | |
| 503-29340 | Ø9×340 mm | In distribution |
| 507-52532 | In distribution | |
| 507-72532 | In distribution | |
| 507-23012 | In distribution | |
| 507-52542 | In distribution | |
| 503-21340 | Ø11×340 mm | In distribution |
| 508-30201 | In distribution | |
| 509-03160 | In distribution | |
| 508-31000 | In distribution | |
| 507-42536 | In distribution | |
| 502-11285 | In distribution | |
| 502-09330 | In distribution | |
| 507-82536 | In distribution | |
| 502-12330 | In distribution | |
| 507-92542 | In distribution | |
| 502-11330 | In distribution | |
| 508-30100 | In distribution | |
| 502-08285 | In distribution | |
| 502-11375 | In distribution | |
| 503-20340 | Ø10×340 mm | In distribution |
| 503-20360 | Ø10×360 mm | In distribution |
| 503-33340 | Ø13×340 mm | In distribution |
| 507-22510 | In distribution | |
| 507-22509 | In distribution | |
| 502-13270 | In distribution | |
| 502-10405 | In distribution | |
| 503-39320 | Ø9×320 mm | In distribution |
| 507-92540 | In distribution | |
| 507-82534 | In distribution | |
| 503-32400 | Ø12×400 mm | In distribution |
| 503-39340 | Ø9×340 mm | In distribution |
| 507-52534 | In distribution | |
| 502-08420 | In distribution | |
| 502-13255 | In distribution | |
| 502-12270 | In distribution | |
| 507-72536 | In distribution | |
| 509-03180 | In distribution | |
| 502-10330 | In distribution | |
| 507-13012 | In distribution | |
| 507-13010 | In distribution | |
| 502-12300 | In distribution | |
| 502-12315 | In distribution | |
| 507-92536 | In distribution | |
| 530-00005 | In distribution | |
| 507-42540 | In distribution | |
| 502-12345 | In distribution | |
| 502-10285 | In distribution | |
| 507-12510 | In distribution | |
| 502-09360 | In distribution | |
| 507-62532 | In distribution | |
| 507-32512 | In distribution | |
| 503-31380 | Ø11×380 mm | In distribution |
| 503-23340 | Ø13×340 mm | In distribution |
| 507-42532 | In distribution | |
| 502-09270 | In distribution | |
| 502-10390 | In distribution | |
| 503-22360 | Ø12×360 mm | In distribution |
| 502-13360 | In distribution | |
| 503-29360 | Ø9×360 mm | In distribution |
| 509-08260 | In distribution | |
| 502-10375 | In distribution | |
| 503-29380 | Ø9×380 mm | In distribution |
| 509-09300 | In distribution | |
| 502-13300 | In distribution | |
| 503-32360 | Ø12×360 mm | In distribution |
| 503-30380 | Ø10×380 mm | In distribution |
| 502-11420 | In distribution | |
| 509-08280 | In distribution | |
| 509-07280 | In distribution | |
| 509-09280 | In distribution | |
| 502-08390 | In distribution | |
| 502-10270 | In distribution | |
| 507-82540 | In distribution | |
| 507-62536 | In distribution | |
| 530-00000 | In distribution | |
| 502-08300 | In distribution | |
| 502-11315 | In distribution | |
| 503-21320 | Ø11×320 mm | In distribution |
| 502-12390 | In distribution | |
| 530-01020 | In distribution | |
| 508-30000 | In distribution | |
| 503-32340 | Ø12×340 mm | In distribution |
| 533-20300 | In distribution | |
| 507-92538 | In distribution | |
| 509-02180 | In distribution | |
| 507-72538 | In distribution | |
| 508-30001 | In distribution | |
| 507-13011 | 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 |
|---|---|
| K230071 | 2024-08-22 |
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.