Pivox™ Oblique Lateral Spinal System
Tray 2201004 Pivox 20MM 12-18 DEG Trials
14manufacturers in China registered for this device type
136catalogue numbers in this listing
20510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K152277 |
| Record published | 2016-01-20 |
| Record revised | 2022-09-16 (version 9) |
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 30 to 60 mm; width 20 to 27 mm; height 8 to 18 mm; angle 0 to 18 ° |
| Distribution end date | 2025-06-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2192360 | In distribution | |
| 2191250 | In distribution | |
| 2113450 | Width 20.0 mm | In distribution |
| 2111150 | Length 50.0 mm | In distribution |
| 2201002 | In distribution | |
| 2170555 | In distribution | |
| 2173645 | In distribution | |
| 2113640 | Width 20.0 mm | In distribution |
| 2133645 | Angle 18.0 ° | In distribution |
| 2171550 | In distribution | |
| 2171340 | In distribution | |
| 2193460 | In distribution | |
| 2132640 | Length 40.0 mm | In distribution |
| 2192355 | In distribution | |
| 2192655 | In distribution | |
| 2111460 | Angle 6.0 ° | In distribution |
| 2192445 | In distribution | |
| 2171560 | In distribution | |
| 2113355 | Length 55.0 mm | In distribution |
| 2191350 | In distribution | |
| 2192650 | In distribution | |
| 2112655 | Width 20.0 mm | In distribution |
| 2172255 | In distribution | |
| 2130155 | Length 55.0 mm | In distribution |
| 2140145 | Length 45.0 mm | In distribution |
| 2192640 | In distribution | |
| 2170345 | In distribution | |
| 2190450 | In distribution | |
| 2131560 | Length 60.0 mm | In distribution |
| 2171255 | In distribution | |
| 2130460 | Height 14.0 mm | In distribution |
| 2191445 | In distribution | |
| 2170355 | In distribution | |
| 2112245 | Height 10.0 mm | In distribution |
| 2133660 | Angle 18.0 ° | In distribution |
| 2171455 | In distribution | |
| 2132345 | Angle 12.0 ° | In distribution |
| 2110355 | Height 12.0 mm | In distribution |
| 2171360 | In distribution | |
| 2173560 | In distribution | |
| 2170145 | In distribution | |
| 2192550 | In distribution | |
| 2171540 | In distribution | |
| 2192455 | In distribution | |
| 2191560 | In distribution | |
| 2171260 | In distribution | |
| 2171440 | In distribution | |
| 2133540 | Angle 18.0 ° | In distribution |
| 2111160 | Length 60.0 mm | In distribution |
| 2193650 | In distribution | |
| 2171445 | In distribution | |
| 2190155 | In distribution | |
| 2130550 | Height 16.0 mm | In distribution |
| 2133650 | Height 18.0 mm | In distribution |
| 2172540 | In distribution | |
| 2171250 | In distribution | |
| 2132660 | Width 27.0 mm | In distribution |
| 2130240 | Width 27.0 mm | In distribution |
| 2110545 | Angle 0.0 ° | In distribution |
| 2190550 | In distribution | |
| 2192645 | In distribution | |
| 2112540 | Angle 12.0 ° | In distribution |
| 2110255 | Height 10.0 mm | In distribution |
| 2172655 | In distribution | |
| 2171255 | In distribution | |
| 2140135 | Length 35.0 mm | In distribution |
| 2112545 | Length 45.0 mm | In distribution |
| 2170160 | In distribution | |
| 2171355 | In distribution | |
| 2110260 | Height 10.0 mm | In distribution |
| 2172660 | In distribution | |
| 2130450 | Width 27.0 mm | In distribution |
| 2170350 | In distribution | |
| 2172355 | In distribution | |
| 2112645 | Length 45.0 mm | In distribution |
| 2112455 | Length 55.0 mm | In distribution |
| 2201004 | In distribution | |
| 2132560 | Width 27.0 mm | In distribution |
| 2172460 | In distribution | |
| 2171350 | In distribution | |
| 2171155 | In distribution | |
| 2193440 | In distribution | |
| 2140130 | Length 30.0 mm | In distribution |
| 2173455 | In distribution | |
| 2130350 | Width 27.0 mm | In distribution |
| 2140011 | In distribution | |
| 2162000 | In distribution | |
| 2190240 | In distribution | |
| 2173355 | In distribution | |
| 2170455 | In distribution | |
| 2171150 | In distribution | |
| 2170450 | In distribution | |
| 2170445 | In distribution | |
| 2170550 | In distribution | |
| 2140140 | Length 40.0 mm | In distribution |
| 2192460 | In distribution | |
| 2171545 | In distribution | |
| 2112360 | Length 60.0 mm | In distribution |
| 2133440 | Length 40.0 mm | In distribution |
| 2172345 | In distribution | |
| 2190560 | In distribution | |
| 2113660 | Length 60.0 mm | In distribution |
| 2130260 | Width 27.0 mm | In distribution |
| 2192350 | In distribution | |
| 2140020 | In distribution | |
| 2191450 | In distribution | |
| 2110540 | Angle 0.0 ° | In distribution |
| 2132645 | Width 27.0 mm | In distribution |
| 2110350 | Length 50.0 mm | In distribution |
| 2191340 | In distribution | |
| 2130255 | Width 27.0 mm | In distribution |
| 2190145 | In distribution | |
| 2190150 | In distribution | |
| 2111350 | Length 50.0 mm | In distribution |
| 2190545 | In distribution | |
| 2191545 | In distribution | |
| 2190455 | In distribution | |
| 2133640 | Width 27.0 mm | In distribution |
| 2110250 | Angle 0.0 ° | In distribution |
| 2111140 | Angle 6.0 ° | In distribution |
| 2201001 | In distribution | |
| 2172650 | In distribution | |
| 2190260 | In distribution | |
| 2191260 | In distribution | |
| 2173555 | In distribution | |
| 2172255 | In distribution | |
| 2172240 | In distribution | |
| 2122455 | Length 55.0 mm | Withdrawn |
| 2123660 | Height 18.0 mm | Withdrawn |
| 2122345 | Length 45.0 mm | Withdrawn |
| 2123445 | Height 14.0 mm | Withdrawn |
| 2123550 | Length 50.0 mm | Withdrawn |
| 2122460 | Width 23.5 mm | Withdrawn |
| 2123455 | Width 23.5 mm | Withdrawn |
| 2122445 | Angle 12.0 ° | Withdrawn |
| 2122360 | Angle 12.0 ° | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140417 | 2014-07-09 |
| K081038 | 2008-08-15 |
| K063100 | 2007-02-23 |
| K061274 | 2006-05-25 |
| K050117 | 2005-02-17 |
| K043151 | 2005-02-01 |
| K031782 | 2005-02-01 |
| K042922 | 2004-11-19 |
| K042499 | 2004-10-07 |
| K042235 | 2004-09-17 |
| K042025 | 2004-08-25 |
| K041217 | 2004-05-28 |
| K040962 | 2004-05-14 |
| K032265 | 2003-08-11 |
| K030327 | 2003-02-26 |
| K021761 | 2002-09-17 |
| K021461 | 2002-07-22 |
| K021226 | 2002-05-13 |
| K013665 | 2002-01-29 |
| K994239 | 2000-06-19 |
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.