Telegraph®
71 catalogue numbers from 250698 - LONG HUMERAL NAIL, Ø7/L290, TIT, listed by Fournitures Hospitalieres Industrie, 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
71catalogue 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 | Fournitures Hospitalieres Industrie, United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| 510(k) | K042332 |
| Record published | 2015-10-24 |
| Record revised | 2025-02-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 250698 – LONG HUMERAL NAIL, Ø7/L290, TITANIUM | In distribution | |
| 248110 – DISTAL COTTER FOR LONG NAIL, Ø4/L24, INOX | In distribution | |
| 246085 – LONG HUMERAL NAIL M5, Ø7/L230, INOX | In distribution | |
| 246095 – LONG HUMERAL NAIL M5, Ø8/L310, INOX | In distribution | |
| 250847 – LONG HUMERAL NAIL, Ø10/L290, TITANIUM | In distribution | |
| 250839 – LONG HUMERAL NAIL, Ø10/L210, TITANIUM | In distribution | |
| 246097 – LONG HUMERAL NAIL M5, Ø9/L230, INOX | In distribution | |
| 253693 – SELF-TAPPING SCREW, Ø4 / L35, INOX | In distribution | |
| 250717 – SELF-TAPPING SCREW, Ø4 / L30, TITANIUM | In distribution | |
| 250705 – LONG HUMERAL NAIL, Ø8/L290, TITANIUM | In distribution | |
| 253988 – DISTAL COTTER FOR LONG NAIL, Ø4/L32, TITANIUM | In distribution | |
| 248113 – DISTAL COTTER FOR LONG NAIL, Ø4/L32, INOX | In distribution | |
| 250712 – LONG HUMERAL NAIL, Ø9/L290, TITANIUM | In distribution | |
| 250703 – LONG HUMERAL NAIL, Ø8/L250, TITANIUM | In distribution | |
| 250695 – LONG HUMERAL NAIL, Ø7/L230, TITANIUM | In distribution | |
| 250841 – LONG HUMERAL NAIL, Ø10/L230, TITANIUM | In distribution | |
| 253694 – SELF-TAPPING SCREW, Ø4 / L40, INOX | In distribution | |
| 250697 – LONG HUMERAL NAIL, Ø7/L270, TITANIUM | In distribution | |
| 246090 – LONG HUMERAL NAIL M5, Ø8/L210, INOX | In distribution | |
| 250701- LONG HUMERAL NAIL, Ø8/L210, TITANIUM | In distribution | |
| 253986 – DISTAL COTTER FOR LONG NAIL, Ø4/L28, TITANIUM | In distribution | |
| 246099 – LONG HUMERAL NAIL M5, Ø9/L270, INOX | In distribution | |
| 246100 – LONG HUMERAL NAIL M5, Ø9/L290, INOX | In distribution | |
| 253696 – SELF-TAPPING SCREW, Ø4 / L50, INOX | In distribution | |
| 246089 – LONG HUMERAL NAIL M5,Ø7/L310, INOX | In distribution | |
| 246091 – LONG HUMERAL NAIL M5, Ø8/L230, INOX | In distribution | |
| 246096 – LONG HUMERAL NAIL M5, Ø9/L210, INOX | In distribution | |
| 250843 – LONG HUMERAL NAIL, Ø10/L250, TITANIUM | In distribution | |
| 250711 – LONG HUMERAL NAIL, Ø9/L270, TITANIUM | In distribution | |
| 250845 – LONG HUMERAL NAIL, Ø10/L270, TITANIUM | In distribution | |
| 246086 – LONG HUMERAL NAIL M5, Ø7/L250, INOX | In distribution | |
| 250706 – LONG HUMERAL NAIL, Ø8/L310, TITANIUM | In distribution | |
| 248111 – DISTAL COTTER FOR LONG NAIL, Ø4/L28, INOX | In distribution | |
| 246924 – SHORT HUMERAL NAIL M5, Ø7/L150, INOX | In distribution | |
| 250716 – SELF-TAPPING SCREW, Ø4 / L28, TITANIUM | In distribution | |
| 246098 – LONG HUMERAL NAIL M5, Ø9/L250, INOX | In distribution | |
| 250708 – LONG HUMERAL NAIL, Ø9/L210, TITANIUM | In distribution | |
| 250714 – SELF-TAPPING SCREW, Ø4 / L24, TITANIUM | In distribution | |
| 250837 – SHORT HUMERAL NAIL, Ø10, TITANIUM | In distribution | |
| 246925 – SHORT HUMERAL NAIL M5, Ø8/L150, INOX | In distribution | |
| 246093 – LONG HUMERAL NAIL M5, Ø8/L270, INOX | In distribution | |
| 253985 – DISTAL COTTER FOR LONG NAIL, Ø4/L24, TITANIUM | In distribution | |
| 253692 – SELF-TAPPING SCREW, Ø4 / L30, INOX | In distribution | |
| 246087 – LONG HUMERAL NAIL M5, Ø7/L270, INOX | In distribution | |
| 250696 – LONG HUMERAL NAIL, Ø7/L250, TITANIUM | In distribution | |
| 250693 – SHORT HUMERAL NAIL, Ø7, TITANIUM | In distribution | |
| 250699 – LONG HUMERAL NAIL, Ø7/L310, TITANIUM | In distribution | |
| 250702 – LONG HUMERAL NAIL, Ø8/L230, TITANIUM | In distribution | |
| 253987 – DISTAL COTTER FOR LONG NAIL, Ø4/L30, TITANIUM | In distribution | |
| 250707 – SHORT HUMERAL NAIL, Ø9, TITANIUM | In distribution | |
| 250704 – LONG HUMERAL NAIL, Ø8/L270, TITANIUM | In distribution | |
| 246094 – LONG HUMERAL NAIL M5, Ø8/L290, INOX | In distribution | |
| 246101 – LONG HUMERAL NAIL M5, Ø9/L310, INOX | In distribution | |
| 250700 – SHORT HUMERAL NAIL, Ø8, TITANIUM | In distribution | |
| 246092 – LONG HUMERAL NAIL M5, Ø8/L250, INOX | In distribution | |
| 250728 – SELF-TAPPING SCREW, Ø4 / L50, TITANIUM | In distribution | |
| 250722 – SELF-TAPPING SCREW, Ø4 / L40, TITANIUM | In distribution | |
| 253695 – SELF-TAPPING SCREW, Ø4 / L45, INOX | In distribution | |
| 248112 – DISTAL COTTER FOR LONG NAIL, Ø4/L30, INOX | In distribution | |
| 250849 – LONG HUMERAL NAIL, Ø10/L310, TITANIUM | In distribution | |
| 250720 – SELF-TAPPING SCREW, Ø4 / L35, TITANIUM | In distribution | |
| 250694 – LONG HUMERAL NAIL, Ø7/L210, TITANIUM | In distribution | |
| 253691 – SELF-TAPPING SCREW, Ø4 / L28, INOX | In distribution | |
| 250709 – LONG HUMERAL NAIL, Ø9/L230, TITANIUM | In distribution | |
| 250725 – SELF-TAPPING SCREW, Ø4 / L45, TITANIUM | In distribution | |
| 246926 – SHORT HUMERAL NAIL M5, Ø9/L150, INOX | In distribution | |
| 246084 – LONG HUMERAL NAIL M5, Ø7/L210, INOX | In distribution | |
| 253690 – SELF-TAPPING SCREW, Ø4 / L24, INOX | In distribution | |
| 250710 – LONG HUMERAL NAIL, Ø9/L250, TITANIUM | In distribution | |
| 246088 – LONG HUMERAL NAIL M5, Ø7/L290, INOX | In distribution | |
| 250713 – LONG HUMERAL NAIL, Ø9/L310, TITANIUM | 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 |
|---|---|
| K150471 | 2015-05-22 |
| K150463 | 2015-05-22 |
| K052058 | 2005-08-22 |
| K042332 | 2004-10-07 |
| K033510 | 2003-12-03 |
| K023241 | 2002-12-24 |
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.