Valor
24 catalogue numbers from 4151150070, listed by Wright Medical Technology, Inc., United States, under Rod, Fixation, Intramedullary And Accessories. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
24catalogue numbers in this listing
5recalls 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 | Wright Medical Technology, 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-01 |
| Record revised | 2024-02-19 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 20 to 120 mm; outer diameter 5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4151150070 | Length 70 mm | In distribution |
| 4151150065 | Length 65 mm | In distribution |
| 4151150035 | Length 35 mm | In distribution |
| 4151200001 | Locking | In distribution |
| 4151150050 | Outer Diameter 5 mm | In distribution |
| 4151150115 | Length 115 mm | In distribution |
| 4151150020 | Outer Diameter 5 mm | In distribution |
| 4151150085 | Outer Diameter 5 mm | In distribution |
| 4151150075 | Outer Diameter 5 mm | In distribution |
| 4151150080 | Length 80 mm | In distribution |
| 4151150040 | Length 40 mm | In distribution |
| 4151150090 | Outer Diameter 5 mm | In distribution |
| 4151150110 | Length 110 mm | In distribution |
| 4151200002 | In distribution | |
| 4151150095 | Outer Diameter 5 mm | In distribution |
| 4151150030 | Length 30 mm | In distribution |
| 4151150100 | Length 100 mm | In distribution |
| 4151150025 | Length 25 mm | In distribution |
| 4151150060 | Length 60 mm | In distribution |
| 4151200003 | In distribution | |
| 4151150055 | Length 55 mm | In distribution |
| 4151150105 | Length 105 mm | In distribution |
| 4151150045 | Length 45 mm | In distribution |
| 4151150120 | Length 120 mm | 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
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-03-14 | Class II | Under Investigation by firm | Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. | 47 units | 2020-10-05 |
| 2018-03-14 | Class II | Under Investigation by firm | Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. | 50 units | 2020-10-05 |
| 2016-11-08 | Class II | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. | 54 units | 2020-11-03 |
| 2012-04-05 | Not classified | Device Design | The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage. | 133 units | 2013-01-28 |
| 2012-04-05 | Not classified | Device Design | The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage. | 133 units | 2013-01-28 |
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.