Acumed
2 - 4 deg. 10mm x 5.5mm x 150mm Std. Rod
17manufacturers in China registered for this device type
111catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this 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 | Acumed LLC, United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K143276 |
| Record published | 2023-01-08 |
| Record revised | 2025-11-20 (version 6) |
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 |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4011-3025N-S | In distribution | |
| 4014-0600-S | In distribution | |
| 4014-0705-S | In distribution | |
| 40-0014-S | In distribution | |
| 40-0024-S | In distribution | |
| UL-3021-S | In distribution | |
| 4011-4012N-S | In distribution | |
| 47-0010-S | In distribution | |
| 4010-3614N-S | In distribution | |
| HRH-0822-S | In distribution | |
| 4011-3617N-S | In distribution | |
| HR-0820-S | In distribution | |
| 40-0015-S | In distribution | |
| 4011-4019N-S | In distribution | |
| UL-3025-S | In distribution | |
| HRA-1055-S | In distribution | |
| 4011-3612N-S | In distribution | |
| 4010-2619N-S | In distribution | |
| RH-0728-S | In distribution | |
| 4011-3017N-S | In distribution | |
| HRH-0826-S | In distribution | |
| 47-0009-S | In distribution | |
| 4014-0705 | In distribution | |
| HRH-0828-S | In distribution | |
| RH-0726-S | In distribution | |
| 47-0008-S | In distribution | |
| 4011-4023N-S | In distribution | |
| 40-0008 | In distribution | |
| UL-3027-S | In distribution | |
| UL-3621-S | In distribution | |
| UL-3623-S | In distribution | |
| 4011-3027N-S | In distribution | |
| 40-0026-S | In distribution | |
| 40-0013-S | In distribution | |
| RL-3621-S | In distribution | |
| 40-0001-S | In distribution | |
| 40-0027-S | In distribution | |
| UL-3023-S | In distribution | |
| 4010-3014N-S | In distribution | |
| RL-3023-S | In distribution | |
| HR-0828-S | In distribution | |
| 4011-3621N-S | In distribution | |
| RR-3021-S | In distribution | |
| 40-0031-S | In distribution | |
| 4011-4027N-S | In distribution | |
| RL-3623-S | In distribution | |
| RH-0722-S | In distribution | |
| HR-0824-S | In distribution | |
| 4010-2614N-S | In distribution | |
| 4011-3012N-S | In distribution | |
| 40-0030-S | In distribution | |
| 4010-3011N-S | In distribution | |
| UL-3625-S | In distribution | |
| HR-1055-S | In distribution | |
| 4010-2627N-S | In distribution | |
| 4011-4021N-S | In distribution | |
| 4011-3627N-S | In distribution | |
| RH-0724-S | In distribution | |
| HR-L1115-S | In distribution | |
| 4011-3021N-S | In distribution | |
| 4010-3627N-S | In distribution | |
| RH-0720-S | In distribution | |
| 47-0007-S | In distribution | |
| 40-0021-S | In distribution | |
| HR-4D1055-S | In distribution | |
| 47-0014-S | In distribution | |
| 4010-3027N-S | In distribution | |
| HR-0826-S | In distribution | |
| 4011-3023N-S | In distribution | |
| UL-3627-S | In distribution | |
| RR-3023-S | In distribution | |
| 4014-0715 | In distribution | |
| HRH-0820-S | In distribution | |
| 40-0016-S | In distribution | |
| 4010-3619N-S | In distribution | |
| 4011-3623N-S | In distribution | |
| 4014-0715-S | In distribution | |
| 40-0021 | In distribution | |
| RH-0730-S | In distribution | |
| HR-0822-S | In distribution | |
| 47-0015-S | In distribution | |
| RL-3619-S | In distribution | |
| 4011-3019N-S | In distribution | |
| 4010-3019N-S | In distribution | |
| RL-3021-S | In distribution | |
| 40-0025-S | In distribution | |
| 4014-0710 | In distribution | |
| 40-0029-S | In distribution | |
| 4010-2611N-S | In distribution | |
| 47-0006-S | In distribution | |
| 4014-0600 | In distribution | |
| 47-0016-S | In distribution | |
| HR-1115-S | In distribution | |
| 47-0013-S | In distribution | |
| 4011-3625N-S | In distribution | |
| 47-0012-S | In distribution | |
| 40-0028-S | In distribution | |
| RR-3019-S | In distribution | |
| 47-0011-S | In distribution | |
| HRA-1065-S | In distribution | |
| HRH-0824-S | In distribution | |
| RL-3019-S | In distribution | |
| 4011-3619N-S | In distribution | |
| RR-3621-S | In distribution | |
| RR-3619-S | In distribution | |
| 40-0034 | In distribution | |
| 4010-3611N-S | In distribution | |
| 4011-4017N-S | In distribution | |
| 4011-4025N-S | In distribution | |
| RR-3623-S | In distribution | |
| 4014-0710-S | 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 |
|---|---|
| K143276 | 2015-02-05 |
| K071944 | 2007-08-09 |
| K031438 | 2003-07-17 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-03-07 | Not classified | Labeling mix-ups | The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates. | 12 rods | 2012-07-25 |
| 2008-08-21 | Not classified | Other | Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material. | 36 devices | 2010-05-14 |
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.