Phoenix Tibial Nail System
95 catalogue numbers from 40342, 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
95catalogue 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) | K063570 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 6) |
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 |
|---|---|---|
| 40342 | 9.0 MM 420 MM | In distribution |
| 40636 | 10.5 MM 360 MM | In distribution |
| 14-441229 | 13.5 MM 290 MM | In distribution |
| 40937 | 12.0 MM 370 MM | In distribution |
| 40338 | 9.0 MM 380 MM | In distribution |
| 40331 | 9.0 MM 310 MM | In distribution |
| 40925 | 12.0 MM 250 MM | In distribution |
| 14-441230 | 13.5 MM 300 MM | In distribution |
| 40335 | 9.0 MM 350 MM | In distribution |
| 40936 | 12.0 MM 360 MM | In distribution |
| 14-441226 | 13.5 MM 260 MM | In distribution |
| 40327 | 9.0 MM 270 MM | In distribution |
| 40926 | 12.0 MM 260 MM | In distribution |
| 40933 | 12.0 MM 330 MM | In distribution |
| 40932 | 12.0 MM 320 MM | In distribution |
| 40037 | 7.5 MM 370 MM | In distribution |
| 40029 | 7.5 MM 290 MM | In distribution |
| 14-441242 | 13.5 MM 420 MM | In distribution |
| 40033 | 7.5 MM 330 MM | In distribution |
| 40940 | 12.0 MM 400 MM | In distribution |
| 14-441238 | 13.5 MM 380 MM | In distribution |
| 14-441231 | 13.5 MM 310 MM | In distribution |
| 40924 | 12.0 MM 240 MM | In distribution |
| 14-441237 | 13.5 MM 370 MM | In distribution |
| 40630 | 10.5 MM 300 MM | In distribution |
| 40641 | 10.5 MM 410 MM | In distribution |
| 40625 | 10.5 MM 250 MM | In distribution |
| 40035 | 7.5 MM 350 MM | In distribution |
| 40935 | 12.0 MM 350 MM | In distribution |
| 14-441233 | 13.5 MM 330 MM | In distribution |
| 40030 | 7.5 MM 300 MM | In distribution |
| 40334 | 9.0 MM 340 MM | In distribution |
| 40032 | 7.5 MM 320 MM | In distribution |
| 40632 | 10.5 MM 320 MM | In distribution |
| 40326 | 9.0 MM 260 MM | In distribution |
| 40337 | 9.0 MM 370 MM | In distribution |
| 40041 | 7.5 MM 410 MM | In distribution |
| 40329 | 9.0 MM 290 MM | In distribution |
| 40633 | 10.5 MM 330 MM | In distribution |
| 40939 | 12.0 MM 390 MM | In distribution |
| 40025 | 7.5 MM 250 MM | In distribution |
| 40026 | 7.5 MM 260 MM | In distribution |
| 40639 | 10.5 MM 390 MM | In distribution |
| 40027 | 7.5 MM 270 MM | In distribution |
| 40941 | 12.0 MM 410 MM | In distribution |
| 40637 | 10.5 MM 370 MM | In distribution |
| 40628 | 10.5 MM 280 MM | In distribution |
| 14-441235 | 13.5 MM 350 MM | In distribution |
| 14-441241 | 13.5 MM 410 MM | In distribution |
| 14-441234 | 13.5 MM 340 MM | In distribution |
| 40328 | 9.0 MM 280 MM | In distribution |
| 14-441232 | 13.5 MM 320 MM | In distribution |
| 40031 | 7.5 MM 310 MM | In distribution |
| 40629 | 10.5 MM 290 MM | In distribution |
| 14-441240 | 13.5 MM 400 MM | In distribution |
| 40340 | 9.0 MM 400 MM | In distribution |
| 14-441225 | 13.5 MM 250 MM | In distribution |
| 40627 | 10.5 MM 270 MM | In distribution |
| 40635 | 10.5 MM 350 MM | In distribution |
| 40929 | 12.0 MM 290 MM | In distribution |
| 14-441239 | 13.5 MM 390 MM | In distribution |
| 40942 | 12.0 MM 420 MM | In distribution |
| 40934 | 12.0 MM 340 MM | In distribution |
| 40341 | 9.0 MM 410 MM | In distribution |
| 14-441224 | 13.5 MM 240 MM | In distribution |
| 40324 | 9.0 MM 240 MM | In distribution |
| 40339 | 9.0 MM 390 MM | In distribution |
| 40640 | 10.5 MM 400 MM | In distribution |
| 40626 | 10.5 MM 260 MM | In distribution |
| 14-441228 | 13.5 MM 280 MM | In distribution |
| 40931 | 12.0 MM 310 MM | In distribution |
| 40332 | 9.0 MM 320 MM | In distribution |
| 40330 | 9.0 MM 300 MM | In distribution |
| 40642 | 10.5 MM 420 MM | In distribution |
| 40927 | 12.0 MM 270 MM | In distribution |
| 40631 | 10.5 MM 310 MM | In distribution |
| 40034 | 7.5 MM 340 MM | In distribution |
| 40040 | 7.5 MM 400 MM | In distribution |
| 40638 | 10.5 MM 380 MM | In distribution |
| 40336 | 9.0 MM 360 MM | In distribution |
| 14-441236 | 13.5 MM 360 MM | In distribution |
| 40938 | 12.0 MM 380 MM | In distribution |
| 40028 | 7.5 MM 280 MM | In distribution |
| 40042 | 7.5 MM 420 MM | In distribution |
| 40333 | 9.0 MM 330 MM | In distribution |
| 40634 | 10.5 MM 340 MM | In distribution |
| 14-441227 | 13.5 MM 270 MM | In distribution |
| 40624 | 10.5 MM 240 MM | In distribution |
| 40928 | 12.0 MM 280 MM | In distribution |
| 40039 | 7.5 MM 390 MM | In distribution |
| 40024 | 7.5 MM 240 MM | In distribution |
| 40038 | 7.5 MM 380 MM | In distribution |
| 40930 | 12.0 MM 300 MM | In distribution |
| 40036 | 7.5 MM 360 MM | In distribution |
| 40325 | 9.0 MM 250 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 |
|---|---|
| K070955 | 2007-10-12 |
| K013923 | 2002-02-25 |
| K002278 | 2000-10-23 |
| K002057 | 2000-10-04 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2020-11-25 | Class II | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | 7428 | 2024-05-08 |
| Biomet, Inc. | 510(k) number | 2016-04-01 | Class II | Equipment maintenance | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it ma | 2017-05-23 |
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.