Atlas™ Humeral Nail System
Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 034mm (non-sterile)
17manufacturers in China registered for this device type
41catalogue numbers in this listing
3510(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 | Orthopedic Designs North America, Inc., United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Manufacturer |
| 510(k) | K241484 |
| Record published | 2025-01-14 |
| Record revised | 2025-02-06 (version 2) |
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, manufacturing date, serial number |
| Sizes | Outer diameter 5 to 11 mm; length 5 to 270 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AS5056 | Outer Diameter 5 mm | In distribution |
| AHN5034NS | Length 34 mm | In distribution |
| AS5064 | Outer Diameter 5 mm | In distribution |
| AHN5036NS | Length 36 mm | In distribution |
| AHN11C10L | Outer Diameter 11 mm | In distribution |
| AHN5026NS | Length 26 mm | In distribution |
| AHN5038NS | Length 38 mm | In distribution |
| AHN5032NS | Length 32 mm | In distribution |
| AHN5046NS | Length 46 mm | In distribution |
| AHN08270L | Length 270 mm | In distribution |
| AHN08165L | Length 165 mm | In distribution |
| AHN08180R | Length 180 mm | In distribution |
| AHN08210L | Length 210 mm | In distribution |
| AHN5048NS | Length 48 mm | In distribution |
| AHN5040NS | Length 40 mm | In distribution |
| AS5068 | Outer Diameter 5 mm | In distribution |
| AHN08270R | Length 270 mm | In distribution |
| AHN11C00L | Outer Diameter 11 mm | In distribution |
| AHN08165R | Length 165 mm | In distribution |
| AHN08225L | Length 225 mm | In distribution |
| AS5040 | Outer Diameter 5 mm | In distribution |
| AHN5052NS | Length 52 mm | In distribution |
| AHN08240L | Length 240 mm | In distribution |
| AS5046 | Outer Diameter 5 mm | In distribution |
| AHN5044NS | Length 44 mm | In distribution |
| AHN08255L | Length 255 mm | In distribution |
| AS5044 | Outer Diameter 5 mm | In distribution |
| AHN11C05L | Outer Diameter 11 mm | In distribution |
| AS5052 | Outer Diameter 5 mm | In distribution |
| AS5060 | Outer Diameter 5 mm | In distribution |
| AHN08240R | Length 240 mm | In distribution |
| AHN5028NS | Length 28 mm | In distribution |
| AHN08210R | Length 210 mm | In distribution |
| AS5048 | Outer Diameter 5 mm | In distribution |
| AHN5050NS | Length 50 mm | In distribution |
| AHN08225R | Length 225 mm | In distribution |
| AHN5042NS | Length 42 mm | In distribution |
| AS5042 | Outer Diameter 5 mm | In distribution |
| AHN08255R | Length 255 mm | In distribution |
| AHN5030NS | Length 30 mm | In distribution |
| AHN08180L | Length 180 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173255 | 2018-02-22 |
| K152295 | 2015-11-03 |
| K111352 | 2011-08-22 |
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.