Venture™ Anterior Cervical Plate System
Bone Screw 9791223 4.0X13 Self Drill FIX
14manufacturers in China registered for this device type
162catalogue 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) | K042922 |
| Record published | 2015-08-19 |
| Record revised | 2024-10-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 11 to 19 mm; outer diameter 4 to 4.5 mm; width 11 to 110 mm |
| Distribution end date | 2024-10-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9790211 | Length 11.0 mm | In distribution |
| 9791223 | Length 13.0 mm | In distribution |
| 9795315 | In distribution | |
| 9790060 | Width 60.0 mm | In distribution |
| 9790060 | In distribution | |
| 9790215 | Length 15.0 mm | In distribution |
| 9790075 | Width 75.0 mm | In distribution |
| 9790042 | Width 42.5 mm | In distribution |
| 9790100 | Width 100.0 mm | In distribution |
| 9791323 | In distribution | |
| 9790075 | In distribution | |
| 9790100 | In distribution | |
| 9791030 | In distribution | |
| 9790080 | In distribution | |
| 9795223 | Length 13.0 mm | In distribution |
| 9790019 | In distribution | |
| 9791324 | Outer Diameter 4.0 mm | In distribution |
| 9790035 | Width 35.0 mm | In distribution |
| 9790080 | Width 80.0 mm | In distribution |
| 9795217 | Length 17.0 mm | In distribution |
| 9790050 | In distribution | |
| 9795311 | Outer Diameter 4.5 mm | In distribution |
| 9790311 | Length 11.0 mm | In distribution |
| 9790027 | In distribution | |
| 9790221 | Width 11.0 mm | In distribution |
| 9790213 | In distribution | |
| 9790215 | In distribution | |
| 9790021 | Width 21.0 mm | In distribution |
| 9790312 | Outer Diameter 4.0 mm | In distribution |
| 9791150 | In distribution | |
| 9790045 | Width 45.0 mm | In distribution |
| 9790021 | In distribution | |
| 9795315 | Length 15.0 mm | In distribution |
| 9790105 | In distribution | |
| 9790045 | In distribution | |
| 9790325 | Outer Diameter 4.0 mm | In distribution |
| 9790319 | Length 19.0 mm | In distribution |
| 9790027 | Width 27.5 mm | In distribution |
| 9790055 | In distribution | |
| 9790070 | Width 70.0 mm | In distribution |
| 9795225 | Length 15.0 mm | In distribution |
| 9791227 | In distribution | |
| 9790037 | In distribution | |
| 9790052 | In distribution | |
| 9795219 | Length 19.0 mm | In distribution |
| 9795225 | In distribution | |
| 9790065 | Width 65.0 mm | In distribution |
| 9790317 | In distribution | |
| 9795317 | Length 17.0 mm | In distribution |
| 9790042 | In distribution | |
| 9791327 | In distribution | |
| 9791323 | Outer Diameter 4.0 mm | In distribution |
| 9790035 | In distribution | |
| 9790213 | Length 13.0 mm | In distribution |
| X1205102 | In distribution | |
| 9790315 | Length 15.0 mm | In distribution |
| 9791030 | Width 30.0 mm | In distribution |
| 9795213 | Length 13.0 mm | In distribution |
| 9790070 | In distribution | |
| 9791225 | In distribution | |
| 9790047 | Width 47.5 mm | In distribution |
| 9790055 | Width 55.0 mm | In distribution |
| 9795229 | Length 19.0 mm | In distribution |
| X0107256 | Width 52.5 mm | In distribution |
| 9795327 | Outer Diameter 4.5 mm | In distribution |
| 9790025 | In distribution | |
| 9795215 | Outer Diameter 4.5 mm | In distribution |
| 9795321 | Length 11.0 mm | In distribution |
| 9790050 | Width 50.0 mm | In distribution |
| X1205093 | In distribution | |
| 9791325 | In distribution | |
| X1205101 | In distribution | |
| 9790317 | Outer Diameter 4.0 mm | In distribution |
| 9791223 | In distribution | |
| 9795215 | In distribution | |
| 9790040 | In distribution | |
| 9790023 | Width 23.0 mm | In distribution |
| 9790082 | Width 82.5 mm | In distribution |
| 9795213 | In distribution | |
| 9790062 | In distribution | |
| 9790037 | Width 37.5 mm | In distribution |
| 9790087 | Width 87.5 mm | In distribution |
| 9795227 | In distribution | |
| X1205100 | In distribution | |
| 9795221 | Outer Diameter 4.5 mm | In distribution |
| 9795325 | Length 15.0 mm | In distribution |
| 9790082 | In distribution | |
| X0807003 | Width 87.5 mm | In distribution |
| 9795217 | In distribution | |
| 9795323 | Length 13.0 mm | In distribution |
| 9790019 | Width 19.0 mm | In distribution |
| 9790110 | In distribution | |
| 9790057 | Width 57.5 mm | In distribution |
| 9790040 | Width 40.0 mm | In distribution |
| 9790030 | Width 30.0 mm | In distribution |
| 9790087 | In distribution | |
| 9791224 | Outer Diameter 4.0 mm | In distribution |
| X1205099 | In distribution | |
| 9790095 | In distribution | |
| 9790085 | Width 85.0 mm | In distribution |
| 9790085 | In distribution | |
| 9790105 | Width 105.0 mm | In distribution |
| 9791226 | Length 16.0 mm | In distribution |
| 9790072 | Width 72.5 mm | In distribution |
| 9791327 | Length 17.0 mm | In distribution |
| 9795329 | Length 19.0 mm | In distribution |
| 9795317 | In distribution | |
| 9790067 | Width 67.5 mm | In distribution |
| 9790095 | Width 95.0 mm | In distribution |
| 9790067 | In distribution | |
| 9790032 | In distribution | |
| 9790065 | In distribution | |
| 9795313 | Outer Diameter 4.5 mm | In distribution |
| 9790223 | Width 13.0 mm | In distribution |
| 9790313 | Outer Diameter 4.0 mm | In distribution |
| 9790062 | Width 62.5 mm | In distribution |
| 9790077 | Width 77.5 mm | In distribution |
| 9790023 | In distribution | |
| 9795313 | In distribution | |
| 9790217 | In distribution | |
| 9791326 | Length 16.0 mm | In distribution |
| 9790052 | Width 52.5 mm | In distribution |
| 9790217 | Length 17.0 mm | In distribution |
| 9791322 | Length 12.0 mm | In distribution |
| 9795327 | In distribution | |
| 9790313 | In distribution | |
| 9795227 | Length 17.0 mm | In distribution |
| 9795323 | In distribution | |
| 9791325 | Outer Diameter 4.0 mm | In distribution |
| 9790090 | Width 90.0 mm | In distribution |
| 9791221 | Length 11.0 mm | In distribution |
| 9790025 | Width 25.0 mm | In distribution |
| 9791321 | Outer Diameter 4.0 mm | In distribution |
| 9791150 | Width 50.0 mm | In distribution |
| 9790077 | In distribution | |
| 9790030 | In distribution | |
| 9791227 | Length 17.0 mm | In distribution |
| X0807004 | Width 90.0 mm | In distribution |
| 9790032 | Width 32.5 mm | In distribution |
| 9790090 | In distribution | |
| 9791225 | Length 15.0 mm | In distribution |
| 9790315 | In distribution | |
| 9790057 | In distribution | |
| 9795325 | In distribution | |
| 9790219 | Length 19.0 mm | In distribution |
| 9790110 | Width 110.0 mm | In distribution |
| X0107257 | Width 55.0 mm | In distribution |
| 9790047 | In distribution | |
| 9795223 | In distribution | |
| 9795211 | Outer Diameter 4.5 mm | In distribution |
| 9790072 | In distribution | |
| 9791222 | Outer Diameter 4.0 mm | In distribution |
| 9795319 | Length 19.0 mm | In distribution |
| X1205095 | Withdrawn | |
| X0107254 | Width 32.5 mm | Withdrawn |
| X1205094 | Withdrawn | |
| X1205092 | Withdrawn | |
| X0107255 | Width 35.0 mm | Withdrawn |
| X1205096 | Withdrawn | |
| X0107259 | Width 77.5 mm | Withdrawn |
| X0107258 | Width 75.0 mm | Withdrawn |
| 9790212 | Length 12.0 mm | 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.