Vertex® Reconstruction System
Partially Threaded MAS X1211131 4.5 X 26
11manufacturers in China registered for this device type
830catalogue numbers in this listing
44510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K082728 |
| Record published | 2015-08-14 |
| Record revised | 2019-05-07 (version 6) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 6 to 600 mm; outer diameter 3.2 to 6 mm; width 10 to 40 mm; circumference 3.5 mm |
| Distribution end date | 2025-09-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7756073 | Outer Diameter 4.5 mm | In distribution |
| 6958928 | In distribution | |
| X1211131 | In distribution | |
| X0909589 | Length 6.0 mm | In distribution |
| G7750610 | Outer Diameter 5.0 mm | In distribution |
| 7751710 | Outer Diameter 3.5 mm | In distribution |
| 6902530 | In distribution | |
| 6958830 | In distribution | |
| 6958832 | In distribution | |
| 6958836PT | In distribution | |
| 6958730 | In distribution | |
| 7751824 | In distribution | |
| X0811265 | Length 38.0 mm | In distribution |
| 6955260 | Outer Diameter 3.2 mm | In distribution |
| 7751724 | Outer Diameter 3.5 mm | In distribution |
| 7756069 | In distribution | |
| 7756068 | In distribution | |
| 6958726 | In distribution | |
| 7756071 | In distribution | |
| G6959426 | Outer Diameter 4.0 mm | In distribution |
| X0108024 | Length 46.0 mm | In distribution |
| X1211123 | In distribution | |
| X0412230 | Length 30.0 mm | In distribution |
| 6959510 | In distribution | |
| 7750514 | Outer Diameter 4.5 mm | In distribution |
| 6958848 | In distribution | |
| X0108010 | Length 32.0 mm | In distribution |
| 7753807 | Outer Diameter 3.5 mm | In distribution |
| 6959532 | In distribution | |
| 6900270 | Length 100.0 mm | In distribution |
| 7753705 | Outer Diameter 5.5 mm | In distribution |
| X1211107 | In distribution | |
| X0108012 | Outer Diameter 3.5 mm | In distribution |
| 6958824 | In distribution | |
| 7756067 | In distribution | |
| X0811284 | Length 46.0 mm | In distribution |
| 7753619A | 19mm | In distribution |
| 6959446 | In distribution | |
| 6900508 | Length 8.0 mm | In distribution |
| X0209556 | Length 40.0 mm | In distribution |
| 6955518 | Length 18.0 mm | In distribution |
| 7751930EP | Length 30.0 mm | In distribution |
| G7755275 | In distribution | |
| 6959438PT | In distribution | |
| 6959544 | In distribution | |
| 6958736PT | In distribution | |
| 6955510 | Length 10.0 mm | In distribution |
| 7751714 | Length 14.0 mm | In distribution |
| 7750346 | In distribution | |
| X1211093 | In distribution | |
| 6958944 | In distribution | |
| 6958950 | In distribution | |
| 7751932EP | Outer Diameter 4.5 mm | In distribution |
| X1211124 | In distribution | |
| X0412225 | Length 20.0 mm | In distribution |
| 7753865 | Length 65.0 mm | In distribution |
| X0811260 | Length 28.0 mm | In distribution |
| 6900610 | Outer Diameter 4.0 mm | In distribution |
| X1211139 | In distribution | |
| 6958718PT | In distribution | |
| 7753765 | Outer Diameter 3.5 mm | In distribution |
| 6900622 | Outer Diameter 4.0 mm | In distribution |
| 7751724PT | Outer Diameter 3.5 mm | In distribution |
| X0811281 | Length 40.0 mm | In distribution |
| 7752535 | In distribution | |
| X1111086 | In distribution | |
| X0108011 | Length 33.0 mm | In distribution |
| G7753890 | 3.5mm x 90mm | In distribution |
| 6958826PT | In distribution | |
| 7751724EP | Outer Diameter 3.5 mm | In distribution |
| 6959422PT | In distribution | |
| 6955414 | Length 14.0 mm | In distribution |
| 6955960 | 10mm | In distribution |
| 6958916 | In distribution | |
| 7755275 | Outer Diameter 3.5 mm | In distribution |
| 6958740PT | In distribution | |
| X0811287 | Length 52.0 mm | In distribution |
| 6958946 | In distribution | |
| 7755270 | Outer Diameter 3.5 mm | In distribution |
| 6900616 | Length 16.0 mm | In distribution |
| X1211096 | In distribution | |
| 6902135 | Width 10.0 mm | In distribution |
| X0811273 | Length 24.0 mm | In distribution |
| 7755274 | Outer Diameter 3.5 mm | In distribution |
| 7752527 | LARGE | In distribution |
| X0811263 | Length 34.0 mm | In distribution |
| X0108014 | Length 36.0 mm | In distribution |
| X1211098 | In distribution | |
| 6958724 | In distribution | |
| 6958824PT | In distribution | |
| 6958812 | In distribution | |
| 7751734 | Length 34.0 mm | In distribution |
| 6958822 | In distribution | |
| 7751712EP | Length 12.0 mm | In distribution |
| 7756074 | Outer Diameter 6.0 mm | In distribution |
| 6959432PT | In distribution | |
| 6955240 | Outer Diameter 3.2 mm | In distribution |
| X0412239 | Length 48.0 mm | In distribution |
| 6958820PT | In distribution | |
| X0811258 | Length 24.0 mm | In distribution |
| 6958814 | In distribution | |
| 6900120 | Length 120.0 mm | In distribution |
| X0412236 | Length 42.0 mm | In distribution |
| 7756072 | In distribution | |
| 6958834PT | In distribution | |
| 7751830EP | In distribution | |
| 6958832PT | In distribution | |
| 7751832EP | In distribution | |
| 7753770 | Outer Diameter 3.5 mm | In distribution |
| G7755278 | In distribution | |
| X1211141 | In distribution | |
| 6955506 | Outer Diameter 4.5 mm | In distribution |
| 7752536 | In distribution | |
| X1211134 | In distribution | |
| X0108030 | Length 52.0 mm | In distribution |
| 6904045 | 4.5mm | In distribution |
| 6958732 | In distribution | |
| 6955410 | Outer Diameter 4.0 mm | In distribution |
| X1211091 | In distribution | |
| X1211108 | In distribution | |
| 6900518 | Length 18.0 mm | In distribution |
| 7753720 | Outer Diameter 3.5 mm | In distribution |
| 7002525 | Small | In distribution |
| 7751816EP | In distribution | |
| X1211113 | In distribution | |
| 7753785 | Outer Diameter 3.5 mm | In distribution |
| 7751824PT | In distribution | |
| 6958920 | In distribution | |
| X0108025 | Length 47.0 mm | In distribution |
| 7753880 | Length 80.0 mm | In distribution |
| 6958912 | In distribution | |
| 6958924 | In distribution | |
| X0811262 | Length 32.0 mm | In distribution |
| X0412229 | Length 28.0 mm | In distribution |
| 6958932 | In distribution | |
| 6955516 | Length 16.0 mm | In distribution |
| 6900606 | Length 6.0 mm | In distribution |
| 6900524 | Length 24.0 mm | In distribution |
| 6904060 | 6.0mm | In distribution |
| G7750612 | Outer Diameter 5.0 mm | In distribution |
| X0811267 | Length 42.0 mm | In distribution |
| 6959972 | In distribution | |
| 7002500 | In distribution | |
| X1211136 | In distribution | |
| 7751820EP | In distribution | |
| 6958720PT | In distribution | |
| 6959536 | In distribution | |
| 6900624 | Outer Diameter 4.0 mm | In distribution |
| 7752525 | SMALL | In distribution |
| X1211121 | In distribution | |
| 7751924EP | Length 24.0 mm | In distribution |
| X1211104 | In distribution | |
| 6958838PT | In distribution | |
| 6958724PT | In distribution | |
| 7750608 | Length 8.0 mm | In distribution |
| 6958842 | In distribution | |
| 6958952 | In distribution | |
| 6959430 | In distribution | |
| 7755231 | Length 100.0 mm | In distribution |
| 7750088 | Length 300.0 mm | In distribution |
| 7755122 | Rod diameter span 3.2/3.5 MM | In distribution |
| X0412237 | Length 44.0 mm | In distribution |
| X0808177 | Length 15.0 mm | In distribution |
| 7752510 | In distribution | |
| X1111084 | In distribution | |
| 6958818 | In distribution | |
| 7751826PT | In distribution | |
| 7753520 | In distribution | |
| 6959540 | In distribution | |
| 7753740 | Length 40.0 mm | In distribution |
| 6959418 | In distribution | |
| X1211144 | In distribution | |
| G7750015 | In distribution | |
| X0508078 | Length 36.0 mm | In distribution |
| 7751822 | In distribution | |
| X0811253 | Length 44.0 mm | In distribution |
| 7751810EP | In distribution | |
| 6900522 | Length 22.0 mm | In distribution |
| X0412223 | Length 16.0 mm | In distribution |
| X0811250 | Length 38.0 mm | In distribution |
| X0811286 | Length 50.0 mm | In distribution |
| 7753704 | Length 600.0 mm | In distribution |
| X1111082 | In distribution | |
| 7751714EP | Outer Diameter 3.5 mm | In distribution |
| X0108016 | Length 38.0 mm | In distribution |
| X1108073 | In distribution | |
| X0209555 | Length 35.0 mm | In distribution |
| X1111085 | In distribution | |
| 6958828PT | In distribution | |
| 6904090 | 9.0mm | In distribution |
| 6958714 | In distribution | |
| 6902525 | In distribution | |
| X0108021 | Outer Diameter 3.5 mm | In distribution |
| X1211135 | In distribution | |
| X0412220 | Length 10.0 mm | In distribution |
| 7751712 | Length 12.0 mm | In distribution |
| 7751716EP | Length 16.0 mm | In distribution |
| 6958734PT | In distribution | |
| X0310008 | In distribution | |
| 6958712 | In distribution | |
| G7750616 | Outer Diameter 5.0 mm | In distribution |
| 7753890 | Length 90.0 mm | In distribution |
| 7750348 | 3.5mm/4.0mm TO 5.5mm | In distribution |
| X1011235 | In distribution | |
| 7753884 | In distribution | |
| 7753840 | Outer Diameter 3.5 mm | In distribution |
| 7753825 | Outer Diameter 3.5 mm | In distribution |
| X0411397 | Outer Diameter 3.5 mm | In distribution |
| X1211125 | In distribution | |
| 6959550 | In distribution | |
| 7753895 | Outer Diameter 3.5 mm | In distribution |
| X0811266 | Length 40.0 mm | In distribution |
| X0811280 | Length 38.0 mm | In distribution |
| 7751818EP | In distribution | |
| 6950315 | In distribution | |
| 7751828PT | In distribution | |
| G7759970 | LP OC M PLATE – SMALL | In distribution |
| 6958850 | In distribution | |
| 6958940 | In distribution | |
| X1211101 | In distribution | |
| 7751720EP | Outer Diameter 3.5 mm | In distribution |
| 6959971 | In distribution | |
| 6959420 | In distribution | |
| 7751814EP | In distribution | |
| 7751834PT | Outer Diameter 4.0 mm | In distribution |
| 6958740 | In distribution | |
| X0811278 | Length 34.0 mm | In distribution |
| X0108019 | Outer Diameter 3.5 mm | In distribution |
| X0811268 | Length 44.0 mm | In distribution |
| X1211142 | In distribution | |
| X1211116 | In distribution | |
| 7750444 | In distribution | |
| X0412232 | Length 34.0 mm | In distribution |
| X0811282 | Length 42.0 mm | In distribution |
| X1211137 | In distribution | |
| X0811277 | Length 32.0 mm | In distribution |
| 6902130 | Width 10.0 mm | In distribution |
| 6900620 | Outer Diameter 4.0 mm | In distribution |
| 7753820 | Length 20.0 mm | In distribution |
| 6900516 | Length 16.0 mm | In distribution |
| 7751718 | Length 18.0 mm | In distribution |
| 7753760 | Outer Diameter 3.5 mm | In distribution |
| X0412238 | Length 46.0 mm | In distribution |
| 6955508 | Length 8.0 mm | In distribution |
| X1211126 | In distribution | |
| 6900506 | Length 6.0 mm | In distribution |
| 7753845 | Outer Diameter 3.5 mm | In distribution |
| 6959452 | In distribution | |
| 7753835 | Length 35.0 mm | In distribution |
| X1211092 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121191 | 2012-06-29 |
| K102886 | 2011-01-26 |
| K090714 | 2009-04-17 |
| K083071 | 2008-11-14 |
| K081297 | 2008-06-11 |
| K080805 | 2008-04-18 |
| K071942 | 2007-12-11 |
| K062447 | 2007-10-15 |
| K070742 | 2007-09-14 |
| K061591 | 2006-09-08 |
| K061579 | 2006-08-11 |
| K060081 | 2006-02-13 |
| K052734 | 2005-10-21 |
| K052376 | 2005-09-23 |
| K052402 | 2005-09-23 |
| K052180 | 2005-08-23 |
| K050484 | 2005-05-04 |
| K043053 | 2005-04-11 |
| K043020 | 2005-01-07 |
| K042789 | 2004-12-21 |
| K042524 | 2004-10-08 |
| K042498 | 2004-10-07 |
| K042402 | 2004-10-01 |
| K041862 | 2004-09-15 |
| K041282 | 2004-06-10 |
| K030875 | 2003-06-24 |
| K031533 | 2003-06-13 |
| K030816 | 2003-06-06 |
| K023415 | 2002-12-13 |
| K023797 | 2002-12-13 |
| K014296 | 2002-12-10 |
| K023555 | 2002-11-22 |
| K022191 | 2002-08-28 |
| K021061 | 2002-07-25 |
| K022070 | 2002-07-22 |
| K022015 | 2002-07-18 |
| K020709 | 2002-05-09 |
| K020426 | 2002-02-26 |
| K020155 | 2002-02-05 |
| K014267 | 2002-01-25 |
| K003780 | 2001-09-28 |
| K011508 | 2001-06-12 |
| K010181 | 2001-06-12 |
| K001532 | 2000-06-16 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | UDI-DI | 2020-03-26 | Class II | Nonconforming Material/Component | Nonconforming product; length of the product measured shorter than the labeled length. | 83 units. | 2021-03-26 |
| 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 | |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2011-06-28 | Not classified | Other | Screws are longer then size etched on the screw. | 95 units | 2012-12-24 |
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.