Atlantis Essentials™ Anterior Cervical Plate System
Screw G73733032017 4.0X17 SLF-DRL FIX 2P
14manufacturers in China registered for this device type
150catalogue 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) | K152623 |
| Record published | 2016-01-11 |
| Record revised | 2025-07-02 (version 5) |
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 |
| Label carries | lot or batch number |
| Sizes | Length 10 to 212.426 mm; outer diameter 4 to 4.5 mm |
| Distribution end date | 2019-10-24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| G7371319 | Length 19.0 mm | In distribution | |
| 7372542 | Length 42.5 mm | In distribution | |
| G73733042013 | Outer Diameter 4.0 mm | 2 | In distribution |
| G73733142013 | Outer Diameter 4.0 mm | 2 | In distribution |
| G7371335 | Length 35.0 mm | In distribution | |
| G7371337 | Length 37.5 mm | In distribution | |
| G7371327 | Length 27.0 mm | In distribution | |
| G7371360 | Length 60.0 mm | In distribution | |
| G73733141515 | Outer Diameter 4.5 mm | In distribution | |
| G73733141511 | Length 11.0 mm | In distribution | |
| G73733132013 | Outer Diameter 4.0 mm | 2 | In distribution |
| G7371345 | Length 45.0 mm | In distribution | |
| G73733042011 | Length 11.0 mm | 2 | In distribution |
| G73733132011 | Outer Diameter 4.0 mm | 2 | In distribution |
| G73733141513 | Outer Diameter 4.5 mm | In distribution | |
| G73733041511 | Length 11.0 mm | In distribution | |
| G73733132015 | Outer Diameter 4.0 mm | 2 | In distribution |
| G7371323 | Length 23.0 mm | In distribution | |
| G7371342 | Length 42.5 mm | In distribution | |
| G7371321 | Length 21.0 mm | In distribution | |
| G7371340 | Length 40.0 mm | In distribution | |
| G73733041515 | Length 15.0 mm | In distribution | |
| G73733041513 | Length 13.0 mm | In distribution | |
| G73733142015 | Length 15.0 mm | 2 | In distribution |
| 7376004 | Length 212.426 mm | In distribution | |
| G7371325 | Length 25.0 mm | In distribution | |
| G73733032015 | Outer Diameter 4.0 mm | 2 | In distribution |
| G73733032013 | Outer Diameter 4.0 mm | 2 | In distribution |
| G73733032011 | Outer Diameter 4.0 mm | 2 | In distribution |
| G7371355 | Length 55.0 mm | In distribution | |
| G73733142011 | Length 11.0 mm | 2 | In distribution |
| G73733042015 | Outer Diameter 4.0 mm | 2 | In distribution |
| G7371352 | Length 52.5 mm | Withdrawn | |
| G73733032017 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733031511 | Length 11.0 mm | Withdrawn | |
| G73733041019 | Length 19.0 mm | Withdrawn | |
| G73733132020 | Length 20.0 mm | 2 | Withdrawn |
| G73733132511 | Outer Diameter 4.5 mm | 2 | Withdrawn |
| G73733142517 | Length 17.0 mm | 2 | Withdrawn |
| G73733041014 | Length 14.0 mm | Withdrawn | |
| G73733041020 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733041018 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733041517 | Outer Diameter 4.5 mm | Withdrawn | |
| G73713105 | Length 105.0 mm | Withdrawn | |
| G73733131515 | Length 15.0 mm | Withdrawn | |
| G73733031517 | Outer Diameter 4.5 mm | Withdrawn | |
| G73733032511 | Outer Diameter 4.5 mm | 2 | Withdrawn |
| G73733041015 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733032517 | Length 17.0 mm | 2 | Withdrawn |
| G73733032020 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733032012 | Length 12.0 mm | 2 | Withdrawn |
| G73733132014 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733041010 | Length 10.0 mm | Withdrawn | |
| G7371382 | Length 82.5 mm | Withdrawn | |
| G73733042517 | Length 17.0 mm | 2 | Withdrawn |
| G73733042515 | Outer Diameter 4.5 mm | 2 | Withdrawn |
| G73733031013 | Outer Diameter 4.0 mm | Withdrawn | |
| G7371390 | Length 90.0 mm | Withdrawn | |
| G73733131019 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733141014 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733031012 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733031020 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733031016 | Length 16.0 mm | Withdrawn | |
| G73733131012 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733041017 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733032019 | Length 19.0 mm | 2 | Withdrawn |
| G73733132017 | Length 17.0 mm | 2 | Withdrawn |
| G73733141018 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733132010 | Length 10.0 mm | 2 | Withdrawn |
| G73733142019 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733042016 | Length 16.0 mm | 2 | Withdrawn |
| G73733031017 | Length 17.0 mm | Withdrawn | |
| G73733141016 | Outer Diameter 4.0 mm | Withdrawn | |
| G7371365 | Length 65.0 mm | Withdrawn | |
| G73733042019 | Length 19.0 mm | 2 | Withdrawn |
| G73733131017 | Length 17.0 mm | Withdrawn | |
| G7371330 | Length 30.0 mm | Withdrawn | |
| G73733132019 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733132018 | Length 18.0 mm | 2 | Withdrawn |
| G73733042020 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733141010 | Length 10.0 mm | Withdrawn | |
| G7371370 | Length 70.0 mm | Withdrawn | |
| G73733042017 | Length 17.0 mm | 2 | Withdrawn |
| G73733142515 | Outer Diameter 4.5 mm | 2 | Withdrawn |
| G73733042012 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733031019 | Length 19.0 mm | Withdrawn | |
| G73733042018 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733032515 | Outer Diameter 4.5 mm | 2 | Withdrawn |
| G73733032018 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733032016 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G7371347 | Length 47.5 mm | Withdrawn | |
| G73733131010 | Outer Diameter 4.0 mm | Withdrawn | |
| G7371377 | Length 77.5 mm | Withdrawn | |
| G73733131018 | Length 18.0 mm | Withdrawn | |
| G73733132513 | Length 13.0 mm | 2 | Withdrawn |
| G73733042513 | Outer Diameter 4.5 mm | 2 | Withdrawn |
| G73733142012 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733031515 | Length 15.0 mm | Withdrawn | |
| G73733032513 | Length 13.0 mm | 2 | Withdrawn |
| G73733042014 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733142014 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733131511 | Length 11.0 mm | Withdrawn | |
| G73733131011 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733131013 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733142010 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733141517 | Length 17.0 mm | Withdrawn | |
| G7371380 | Length 80.0 mm | Withdrawn | |
| G73733141020 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733132515 | Length 15.0 mm | 2 | Withdrawn |
| G7371375 | Length 75.0 mm | Withdrawn | |
| G7371372 | Length 72.5 mm | Withdrawn | |
| G73733042511 | Length 11.0 mm | 2 | Withdrawn |
| G73733131014 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733142513 | Length 13.0 mm | 2 | Withdrawn |
| G73733142020 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G7371332 | Length 32.5 mm | Withdrawn | |
| G7371350 | Length 50.0 mm | Withdrawn | |
| G73733042010 | Outer Diameter 4.5 mm | 2 | Withdrawn |
| G73713110 | Length 110.0 mm | Withdrawn | |
| G73733142016 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733132012 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733131016 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733141012 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733041013 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733032014 | Length 14.0 mm | 2 | Withdrawn |
| G73733141017 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733141011 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733142018 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733132016 | Length 16.0 mm | 2 | Withdrawn |
| G73733031015 | Length 15.0 mm | Withdrawn | |
| G73733041011 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733041012 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733131517 | Length 17.0 mm | Withdrawn | |
| G73733132517 | Outer Diameter 4.5 mm | 2 | Withdrawn |
| G73733031010 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733142511 | Outer Diameter 4.5 mm | 2 | Withdrawn |
| G7371385 | Length 85.0 mm | Withdrawn | |
| G73733031011 | Length 11.0 mm | Withdrawn | |
| G73733141019 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733141013 | Length 13.0 mm | Withdrawn | |
| G73733031513 | Length 13.0 mm | Withdrawn | |
| G73733141015 | Length 15.0 mm | Withdrawn | |
| G73733131513 | Length 13.0 mm | Withdrawn | |
| G73733131015 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733031014 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733031018 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733142017 | Outer Diameter 4.0 mm | 2 | Withdrawn |
| G73733032010 | Length 10.0 mm | 2 | Withdrawn |
| G73733041016 | Outer Diameter 4.0 mm | Withdrawn | |
| G73733131020 | Outer Diameter 4.0 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.