Sonoma Orthopedic Products, Inc
3.2mm X 120mm Mini-CRx Implant, Sterile
17manufacturers in China registered for this device type
107catalogue numbers in this listing
6510(k) clearances naming this product 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 | Arthrex, 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, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Record published | 2015-09-08 |
| Record revised | 2026-03-09 (version 9) |
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, expiry date |
| Distribution end date | 2020-07-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5MT5076 | In distribution | |
| FIB30180L | In distribution | |
| WRX-5470-G-S | In distribution | |
| WRX-6470-G-S | In distribution | |
| ST6900 | In distribution | |
| FIB6000 | In distribution | |
| 3.5mmx65mm Double Lead Cortical Bone Screw | Withdrawn | |
| MINI-CRX®3.2x90mm | Withdrawn | |
| 2.7mm x 30mm Self-Tapping,Sterile Bone Screw | Withdrawn | |
| FIB38130R | Withdrawn | |
| 3.5mmx60mm Quick Thread Screw Sterile | Withdrawn | |
| 3.5mmx14mm Quick Thread Screw Sterile | Withdrawn | |
| 3.0mm x 47mm Jones Bolt | Withdrawn | |
| IN0025 | Withdrawn | |
| FIB38180L | Withdrawn | |
| 3.5mmx60mm Double Lead Cortical Bone Screw | Withdrawn | |
| 3.5mmx55mm Quick Thread Screw Sterile | Withdrawn | |
| 3.5mmx55mm Double Lead Cortical Bone Screw | Withdrawn | |
| 2.7mm x 24mm MINI-CRX Self-Tapping, Bone Screw | Withdrawn | |
| 3.0mm x 40mm Jones Bolt | Withdrawn | |
| FIB30130R | Withdrawn | |
| FST-32120-S | Withdrawn | |
| 2.7mm x 18mm Self-Tapping, Bone Screw | Withdrawn | |
| 2.7mm x 26mm Self-Tapping, Bone Screw | Withdrawn | |
| 2.7mm x 18mm MINI-CRX Self-Tapping, Bone Screw | Withdrawn | |
| FST-32110-S | Withdrawn | |
| 2.7mm x 20mm MINI-CRX Self-Tapping, Bone Screw, Sterile | Withdrawn | |
| 2.7mm x 18mm MINI-CRX Self-Tapping, Bone Screw, Sterile | Withdrawn | |
| 3.5mmx45mm Double Lead Cortical Bone Screw | Withdrawn | |
| 2.7mm x 14mm Self-Tapping, Bone Screw | Withdrawn | |
| 7.6mm Long End Cap Jones Bolt | Withdrawn | |
| 2.7mm x 12mm Self-Tapping, Bone Screw | Withdrawn | |
| WRx Outrigger | Withdrawn | |
| FIB38180R | Withdrawn | |
| 2.7mm x 22mm Self-Tapping, Bone Screw | Withdrawn | |
| FST-32100-S | Withdrawn | |
| 2.7mm x 34mm Self-Tapping, Bone Screw | Withdrawn | |
| CRx DISPOSABLE REMOVAL KIT | Withdrawn | |
| IN0152 | Withdrawn | |
| 9.5mm End Cap Jones Bolt | Withdrawn | |
| FIB38130L | Withdrawn | |
| IN0151 | Withdrawn | |
| 2.7mm x 28mm Self-Tapping,Sterile Bone Screw | Withdrawn | |
| 5MT53840 | Withdrawn | |
| IN0162 | Withdrawn | |
| FIB30180R | Withdrawn | |
| 2.7mm x 20mm Self-Tapping, Bone Screw | Withdrawn | |
| MINI-CRX®3.2x120mm | Withdrawn | |
| 3.5mmx65mm Quick Thread Screw Sterile | Withdrawn | |
| 2.7mm x 16mm MINI-CRX Self-Tapping, Bone Screw | Withdrawn | |
| 2.7mm x 26mm MINI-CRX Self-Tapping, Bone Screw, Sterile | Withdrawn | |
| 2.7mm x 22mm Self-Tapping,Sterile Bone Screw | Withdrawn | |
| 5470 Removal Driver | Withdrawn | |
| 2.7mm x 20mm MINI-CRX Self-Tapping, Bone Screw | Withdrawn | |
| 2.7mm x 16mm Self-Tapping, Bone Screw | Withdrawn | |
| 2.7mm x 26mm MINI-CRX Self-Tapping, Bone Screw | Withdrawn | |
| 2.7mm x 14mm Self-Tapping,Sterile Bone Screw | Withdrawn | |
| CRx DISPOSABLE INTRUMENTS PACKAGE | Withdrawn | |
| 2.7mm x 20mm Self-Tapping,Sterile Bone Screw | Withdrawn | |
| 3.5mmx40mm Double Lead Cortical Bone Screw | Withdrawn | |
| 2.7mm x 18mm Self-Tapping,Sterile Bone Screw | Withdrawn | |
| 3.5mmx50mm Double Lead Cortical Bone Screw | Withdrawn | |
| 3.5mmx50mm Quick Thread Screw Sterile | Withdrawn | |
| 2.7mm x 28mm MINI-CRX Self-Tapping, Bone Screw | Withdrawn | |
| FIB30130L | Withdrawn | |
| 3.5mmx70mm Double Lead Cortical Bone Screw | Withdrawn | |
| 3.5mmx16mm Quick Thread Screw Sterile | Withdrawn | |
| MINI-CRX®3.2x110mm | Withdrawn | |
| 2.7mm x 24mm Self-Tapping,Sterile Bone Screw | Withdrawn | |
| 5MT53847 | Withdrawn | |
| 2.7mm x 30mm Self-Tapping, Bone Screw | Withdrawn | |
| 2.7mm x 22mm MINI-CRX Self-Tapping, Bone Screw, Sterile | Withdrawn | |
| FST-32080-S | Withdrawn | |
| 9.5mm Long End Cap Jones Bolt | Withdrawn | |
| 6470 Removal Driver | Withdrawn | |
| CRX 4mm x 100mm | Withdrawn | |
| MINI-CRX®3.2x100mm | Withdrawn | |
| 3.5mmx18mm Quick Thread Screw Sterile | Withdrawn | |
| MINI-CRX®3.2x80mm | Withdrawn | |
| 4mm x 100mm Sonoma CRx™ WG Sterile | Withdrawn | |
| 2.7mm x 14mm MINI-CRX Self-Tapping, Bone Screw | Withdrawn | |
| 2.7mm x 32mm Self-Tapping,Sterile Bone Screw | Withdrawn | |
| 4mm x 110mm Sonoma CRx™ WG Sterile | Withdrawn | |
| 2.7mm x 26mm Self-Tapping,Sterile Bone Screw | Withdrawn | |
| 2.7mm x 24mm Self-Tapping, Bone Screw | Withdrawn | |
| FST-32090-S | Withdrawn | |
| 3.5mmx40mm Quick Thread Screw Sterile | Withdrawn | |
| IN0148 | Withdrawn | |
| 1.6mm x 9″ K-Wire | Withdrawn | |
| 2.7mm x 34mm Self-Tapping,Sterile Bone Screw | Withdrawn | |
| 3.5mmx70mm Quick Thread Screw Sterile | Withdrawn | |
| 4mm x 120mm Sonoma CRx™ WG Sterile | Withdrawn | |
| 2.7mm x 12mm MINI-CRX Self-Tapping, Bone Screw, Sterile | Withdrawn | |
| Spade-Tip Guide Wire | Withdrawn | |
| 2.7mm x 24mm MINI-CRX Self-Tapping, Bone Screw, Sterile | Withdrawn | |
| 5MT54540 | Withdrawn | |
| 2.7mm x 12mm MINI-CRX Self-Tapping, Bone Screw | Withdrawn | |
| 5MT54547 | Withdrawn | |
| 2.7mm x 32mm Self-Tapping, Bone Screw | Withdrawn | |
| 2.7mm x 16mm MINI-CRX Self-Tapping, Bone Screw, Sterile | Withdrawn | |
| 2.7mm x 28mm Self-Tapping, Bone Screw | Withdrawn | |
| 2.7mm x 22mm MINI-CRX Self-Tapping, Bone Screw | Withdrawn | |
| 2.7mm x 28mm MINI-CRX Self-Tapping, Bone Screw, Sterile | Withdrawn | |
| 3.5mmx45mm Quick Thread Screw Sterile | Withdrawn | |
| 4mm x 130mm Sonoma CRx™ WG Sterile | Withdrawn | |
| 2.7mm x 14mm MINI-CRX Self-Tapping, Bone Screw, Sterile | Withdrawn | |
| 2.7mm x 16mm Self-Tapping,Sterile Bone Screw | Withdrawn |
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 |
|---|---|
| K252016 | 2026-03-20 |
| K252196 | 2026-03-05 |
| K243890 | 2025-01-13 |
| K230257 | 2023-07-17 |
| K221031 | 2022-12-20 |
| K173656 | 2018-07-26 |
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.