Redemption
Revision Nail, 12 x 250
17manufacturers in China registered for this device type
72catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls 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 | Vilex LLC, United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K231343 |
| Record published | 2026-01-14 |
| Record revised | 2026-04-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: N/A |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RHFN12-250T-RV | 12mm dia L250 | In distribution |
| RDS50-115TH | L115 | In distribution |
| RHFN11-250T | 11mm dia L250 | In distribution |
| RHFN12-300T | 12mm dia L300 | In distribution |
| RDS50-32T | L32.5 | In distribution |
| RDS50-110T | L110 | In distribution |
| RHFN12-150T | 12mm dia L150 | In distribution |
| RHFN12-250T | 12mm dia L250 | In distribution |
| RDS50-45T | L45 | In distribution |
| RHFN11-200T-RV | 11mm dia L200 | In distribution |
| RHFN13-300T-RV | 13mm dia L300 | In distribution |
| RD-CP-15 | L1.5 | In distribution |
| RDS50-105T | L105 | In distribution |
| RHFN10-300T | 10mm dia L300 | In distribution |
| RHFN11-300T | 11mm dia L300 | In distribution |
| RDS50-35T | L35 | In distribution |
| RDS50-45TH | L45 | In distribution |
| RDS50-60T | L60 | In distribution |
| RDS50-85TH | L85 | In distribution |
| RDS50-40TH | L40 | In distribution |
| RDS50-22T | L22.5 | In distribution |
| RHFN13-250T-RV | 13mm dia L250 | In distribution |
| RDS50-100TH | L100 | In distribution |
| RHFN12-300T-RV | 12mm dia L300 | In distribution |
| RDS50-110TH | L110 | In distribution |
| RHFN13-200T-RV | 13mm dia L200 | In distribution |
| RHFN11-250T-RV | 11mm dia L250 | In distribution |
| RHFN11-150T | 11mm dia L150 | In distribution |
| RDS50-50T | L50 | In distribution |
| RDS50-125T | L125 | In distribution |
| RDS50-125TH | L125 | In distribution |
| RDS50-115T | L115 | In distribution |
| RDS50-65T | L65 | In distribution |
| RDS50-90T | L90 | In distribution |
| RDS50-100T | L100 | In distribution |
| RDS50-35TH | L35 | In distribution |
| RHFN12-200T | 12mm dia L200 | In distribution |
| RDS50-85T | L85 | In distribution |
| RHFN10-150T | 10mm dia L150 | In distribution |
| RDS50-30T | L30 | In distribution |
| RDS50-75T | L75 | In distribution |
| RHFN10-200T | 10mm dia L200 | In distribution |
| RHFN10-250T | 10mm dia L250 | In distribution |
| RDS50-105TH | L105 | In distribution |
| RDS50-70T | L70 | In distribution |
| RHFN11-300T-RV | 11mm dia L300 | In distribution |
| RDS50-60TH | L60 | In distribution |
| RDS50-40T | L40 | In distribution |
| RDS50-70TH | L70 | In distribution |
| RDS50-25T | L25 | In distribution |
| RDS50-120TH | L120 | In distribution |
| RDS50-32TH | L32.5 | In distribution |
| RDS50-80T | L80 | In distribution |
| RDS50-95TH | L95 | In distribution |
| RDS50-120T | L120 | In distribution |
| RDS50-55TH | L55 | In distribution |
| RDS50-95T | L95 | In distribution |
| RDS50-80TH | L80 | In distribution |
| RD-CP-F | Flush | In distribution |
| RD-CP-50 | L5.0 | In distribution |
| RHFN12-200T-RV | 12mm dia L200 | In distribution |
| RDS50-22TH | L22.5 | In distribution |
| RDS50-25TH | L25 | In distribution |
| RDS50-50TH | L50 | In distribution |
| RDS50-75TH | L75 | In distribution |
| RHFN11-200T | 11mm dia L200 | In distribution |
| RDS50-90TH | L90 | In distribution |
| RDS50-55T | L55 | In distribution |
| RDS50-27TH | L27.5 | In distribution |
| RDS50-30TH | L30 | In distribution |
| RDS50-65TH | L65 | In distribution |
| RDS50-27T | L27.5 | 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 |
|---|---|
| K231343 | 2024-01-30 |
| K102413 | 2011-11-14 |
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 |
|---|---|---|---|---|---|
| 2015-04-22 | Class II | Device Design | Incidence of breakage is higher than expected. | 13 units | 2016-10-30 |
| 2015-04-22 | Class II | Device Design | Incidence of breakage is higher than expected. | 4 units | 2016-10-30 |
| 2015-04-22 | Class II | Device Design | Incidence of breakage is higher than expected. | 7 units | 2016-10-30 |
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.