Uniflex System
40 catalogue numbers from 344170, listed by Biomet Orthopedics, 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
40catalogue numbers in this listing
4510(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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| 510(k) | K982953 |
| Record published | 2015-10-24 |
| Record revised | 2026-02-09 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 344170 | 11MM Ø 70CM LENGTH | In distribution |
| 33-345524 | 6MM Ø 40MM LENGTH | In distribution |
| 33-345528 | 6MM Ø 50MM LENGTH | In distribution |
| 344180 | 11MM Ø 80CM LENGTH | In distribution |
| 33-345548 | 6MM Ø 100MM LENGTH | In distribution |
| 33-345538 | 6MM Ø 75MM LENGTH | In distribution |
| 33-345530 | 6MM Ø 55MM LENGTH | In distribution |
| 344370 | 13MM Ø 70CM LENGTH | In distribution |
| 344065 | 10MM Ø 65CM LENGTH | In distribution |
| 344175 | 11MM Ø 75CM LENGTH | In distribution |
| 344480 | 14MM Ø 80CM LENGTH | In distribution |
| 344060 | 10MM Ø 60CM LENGTH | In distribution |
| 344380 | 13MM Ø 80CM LENGTH | In distribution |
| 344270 | 12MM Ø 70CM LENGTH | In distribution |
| 33-345536 | 6MM Ø 70MM LENGTH | In distribution |
| 33-345522 | 6MM Ø 35MM LENGTH | In distribution |
| 33-345544 | 6MM Ø 90MM LENGTH | In distribution |
| 344275 | 12MM Ø 75CM LENGTH | In distribution |
| 344280 | 12MM Ø 80CM LENGTH | In distribution |
| 345294 | 4MM Ø 54MM LENGTH | In distribution |
| 344475 | 14MM Ø 75CM LENGTH | In distribution |
| 345211 | In distribution | |
| 345296 | 4MM Ø 58MM LENGTH | In distribution |
| 344070 | 10MM Ø 70CM LENGTH | In distribution |
| 33-345546 | 6MM Ø 95MM LENGTH | In distribution |
| 344365 | 13MM Ø 65CM LENGTH | In distribution |
| 344375 | 13MM Ø 75CM LENGTH | In distribution |
| 33-345526 | 6MM Ø 45MM LENGTH | In distribution |
| 33-345520 | 6MM Ø 30MM LENGTH | In distribution |
| 344470 | 14MM Ø 70CM LENGTH | In distribution |
| 33-345532 | 6MM Ø 60MM LENGTH | In distribution |
| 33-345540 | 6MM Ø 80MM LENGTH | In distribution |
| 344075 | 10MM Ø 75CM LENGTH | In distribution |
| 344165 | 11MM Ø 65CM LENGTH | In distribution |
| 33-345534 | 6MM Ø 65MM LENGTH | In distribution |
| 344160 | 11MM Ø 60CM LENGTH | In distribution |
| 344265 | 12MM Ø 65CM LENGTH | In distribution |
| 344080 | 10MM Ø 80CM LENGTH | In distribution |
| 344465 | 14MM Ø 65CM LENGTH | In distribution |
| 33-345542 | 6MM Ø 85MM LENGTH | 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 |
|---|---|
| K070955 | 2007-10-12 |
| K013923 | 2002-02-25 |
| K002278 | 2000-10-23 |
| K002057 | 2000-10-04 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| EBI, LLC | 510(k) number | 2009-04-02 | Not classified | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | 151 | 2009-09-23 |
| EBI, LLC | 510(k) number | 2009-04-02 | Not classified | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | 4 | 2009-09-23 |
| EBI, LLC | 510(k) number | 2009-03-27 | Not classified | Nonconforming Material/Component | Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices. | 5 | 2009-09-23 |
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.