IMPlate
45 catalogue numbers from IMPLATE Nail, Distal Radius, Short, Ti, listed by Skeletal Dynamics L.L.C., under Rod, Fixation, Intramedullary And Accessories. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
45catalogue numbers in this listing
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 | Skeletal Dynamics L.L.C. |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| 510(k) | K092720 |
| Record published | 2015-10-30 |
| Record revised | 2025-02-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 2 to 7 mm; length 2 to 12 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IMPLATE Nail, Distal Radius, Short, Ti | In distribution | |
| Unicortical Screw, 2.8mm x 14.0mm, Ti | Outer Diameter 2.8 mm | In distribution |
| IMPLATE Connector, 2mm x 0° | Length 2 mm | In distribution |
| IMPLATE Drill, Unicortical 3mm x 41mm | In distribution | |
| Unicortical Screw, 2.8mm x 6.0mm, Ti | Outer Diameter 2.8 mm | In distribution |
| IMPLATE Rasp 2, Distal Radius, 7.0mm x 70mm | Outer Diameter 7 mm | In distribution |
| IMPLATE Connector, 12mm x 22.5° | Length 12 mm | In distribution |
| Driver, Mini QC T-7 | In distribution | |
| Unicortical Screw, 2.8mm x 7.0mm, Ti | Outer Diameter 2.8 mm | In distribution |
| IMPLATE Reamer 2, Metacarpal, 3.4mm x 87mm | Outer Diameter 3.4 mm | In distribution |
| IMPLATE Reamer 3, Metacarpal, 4.0mm x 87mm | Outer Diameter 4 mm | In distribution |
| IMPLATE Uni Drill Guide, DRMC Nails | In distribution | |
| IMPLATE Spreader, Wrist Arthrodesis Nails | In distribution | |
| IMPLATE Connector, 2mm x 22.5° | Length 2 mm | In distribution |
| Unicortical Screw, 2.8mm x 8.0mm, Ti | Outer Diameter 2.8 mm | In distribution |
| IMPLATE Connector, 2mm x 7.5° | Length 2 mm | In distribution |
| IMPLATE Connector, 12mm x 15° | Length 12 mm | In distribution |
| IMPLATE Connector, 7mm x 15° | Length 7 mm | In distribution |
| IMPLATE Nail, Metacarpal, Standard, 4.6mm | Outer Diameter 4.6 mm | In distribution |
| Unicortical Screw, 2.8mm x 10.0mm, Ti | Outer Diameter 2.8 mm | In distribution |
| IMPLATE Nail, Metacarpal, Mini | In distribution | |
| IMPLATE Rasp, Flaring and Troughing | In distribution | |
| IMPLATE Uni Drill Guide, Depth Gauge | In distribution | |
| IMPLATE Awl, Wrist Arthrodesis Nails | In distribution | |
| IMPLATE Connector, 12mm x 7.5° | Length 12 mm | In distribution |
| IMPLATE Connector, 7mm x 0° | Length 7 mm | In distribution |
| IMPLATE Uni Drill Guide, Drill Sleeve | In distribution | |
| IMPLATE Rasp 1, Distal Radius, 5.5mm x 70mm | Outer Diameter 5.5 mm | In distribution |
| IMPLATE Reamer 1, Metacarpal, 2.7mm x 87mm | Outer Diameter 2.7 mm | In distribution |
| IMPLATE Nail, Distal Radius, Long, Ti | In distribution | |
| IMPLATE, Minimum Gap Gauge | In distribution | |
| Unicortical Screw, 2.8mm x 12.0mm, Ti | Outer Diameter 2.8 mm | In distribution |
| IMPLATE Nail, Metacarpal, Standard, 4.0mm | Outer Diameter 4 mm | In distribution |
| IMPLATE Connector, 7mm x 7.5° | Length 7 mm | In distribution |
| Unicortical Screw, 2.8mm x 4.0mm, Ti | Outer Diameter 2.8 mm | In distribution |
| IMPLATE Connector, 2mm x 15° | Length 2 mm | In distribution |
| IMPLATE Lock Screw, Unicort. Drill Guide | In distribution | |
| IMPLATE Connector, 12mm x 0° | Length 12 mm | In distribution |
| IMPLATE Connector, 7mm x 22.5° | Length 7 mm | In distribution |
| IMPLATE Reamer 5, Metacarpal, 5.0mm x 87mm | Outer Diameter 5 mm | In distribution |
| IMPLATE Reamer 4, Metacarpal, 4.5mm x 87mm | Outer Diameter 4.5 mm | In distribution |
| Set Screw, 3.0mm x 2.0mm, CoCr | Outer Diameter 2 mm | In distribution |
| Unicortical Screw, 2.8mm x 5.0mm, Ti | Outer Diameter 2.8 mm | In distribution |
| Handle, Mini Quick Connect, Fixed | In distribution | |
| IMPLATE Wrist Arthrodesis Nail System | 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
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.