Atlantis® Anterior Cervical Plate System
Plate 7200180S 80MM Eliteoverlap Sterile
14manufacturers in China registered for this device type
639catalogue 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) | K021461 |
| Record published | 2015-08-19 |
| Record revised | 2024-10-25 (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 |
| Label carries | lot or batch number |
| Sizes | Outer diameter 4 to 4.5 mm; length 2 to 24 mm; width 19 to 110 mm |
| Distribution end date | 2025-12-09 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 976-147 | Width 47.5 mm | In distribution | |
| 876-172 | Width 72.5 mm | In distribution | |
| 7200110 | Width 110.0 mm | In distribution | |
| 876-310 | Length 10.0 mm | In distribution | |
| 876-150 | Width 50.0 mm | In distribution | |
| 876-195 | Width 95.0 mm | In distribution | |
| 3125217 | In distribution | ||
| X0607183 | Width 90.0 mm | In distribution | |
| 7200145 | Width 45.0 mm | In distribution | |
| 7200035 | Width 35.0 mm | In distribution | |
| 3120217 | In distribution | ||
| 3120411 | Outer Diameter 4.0 mm | In distribution | |
| 7200032 | Width 32.5 mm | In distribution | |
| 3120218 | Outer Diameter 4.0 mm | In distribution | |
| 876-815 | Length 15.0 mm | In distribution | |
| X876-618 | Length 18.0 mm | In distribution | |
| 876-160 | Width 60.0 mm | In distribution | |
| 6190037 | In distribution | ||
| 876-013 | Outer Diameter 4.0 mm | In distribution | |
| 876-147 | Width 47.5 mm | In distribution | |
| 876-119 | Width 19.0 mm | In distribution | |
| 3125215 | In distribution | ||
| 876-017 | Length 17.0 mm | In distribution | |
| 7200019 | In distribution | ||
| 976-119 | Width 19.0 mm | In distribution | |
| 876-205 | Width 105.0 mm | In distribution | |
| 7200019S | Width 19.0 mm | In distribution | |
| 876-210 | Width 110.0 mm | In distribution | |
| 3120518 | Length 18.0 mm | In distribution | |
| 3120317 | In distribution | ||
| 6190077 | In distribution | ||
| 6190042 | 42.5mm | In distribution | |
| 876-857 | Outer Diameter 4.5 mm | In distribution | |
| 7200167 | In distribution | ||
| X0512085 | Length 12.0 mm | In distribution | |
| 3120311 | Outer Diameter 4.0 mm | In distribution | |
| 3120517 | In distribution | ||
| 3120211 | In distribution | ||
| X876-160 | Width 60.0 mm | In distribution | |
| 876-155 | Width 55.0 mm | In distribution | |
| 876-320 | Outer Diameter 4.0 mm | In distribution | |
| 876-314 | Outer Diameter 4.0 mm | In distribution | |
| 6190045 | 45mm | In distribution | |
| X0109239 | Width 37.5 mm | In distribution | |
| 3120416 | In distribution | ||
| 6190047 | 47.5mm | In distribution | |
| 3120312 | In distribution | ||
| 876-712 | Length 12.0 mm | In distribution | |
| 7200075 | In distribution | ||
| 7200185 | Width 85.0 mm | In distribution | |
| 3120515S | Length 15.0 mm | 2 | In distribution |
| 3120512 | In distribution | ||
| 7200132 | In distribution | ||
| 7200132 | Width 32.5 mm | In distribution | |
| 3120320 | In distribution | ||
| X0109243 | Width 47.5 mm | In distribution | |
| 876-152 | Width 52.5 mm | In distribution | |
| 876-187 | Width 87.5 mm | In distribution | |
| X0109235 | Width 27.5 mm | In distribution | |
| 876-645 | Length 15.0 mm | In distribution | |
| 876-816 | Outer Diameter 4.0 mm | In distribution | |
| 976-167 | Width 67.5 mm | In distribution | |
| 7200180 | Width 80.0 mm | In distribution | |
| 876-170 | Width 70.0 mm | In distribution | |
| 976-132 | Width 32.5 mm | In distribution | |
| 3120414 | Outer Diameter 4.0 mm | In distribution | |
| 876-145 | Width 45.0 mm | In distribution | |
| 876-615 | Outer Diameter 4.0 mm | In distribution | |
| 7200045 | Width 45.0 mm | In distribution | |
| 7200062 | Width 62.5 mm | In distribution | |
| 7200040 | In distribution | ||
| 6190055 | 55mm | In distribution | |
| 7200130 | In distribution | ||
| 876-813 | Length 13.0 mm | In distribution | |
| X0109242 | Width 45.0 mm | In distribution | |
| 7200072 | Width 72.5 mm | In distribution | |
| 3120515 | In distribution | ||
| 3125513 | In distribution | ||
| 6190057 | In distribution | ||
| 876-057 | Outer Diameter 4.5 mm | In distribution | |
| 3120319 | In distribution | ||
| X976-616 | Outer Diameter 4.0 mm | In distribution | |
| 6190030 | In distribution | ||
| 6190030 | 30mm | In distribution | |
| 7200057 | In distribution | ||
| 3120212 | Length 12.0 mm | In distribution | |
| 6190060 | 60mm | In distribution | |
| 976-170 | Width 70.0 mm | In distribution | |
| 3125311 | In distribution | ||
| 7200025 | In distribution | ||
| 876-716 | Outer Diameter 4.0 mm | In distribution | |
| 3125313S | Length 13.0 mm | In distribution | |
| 876-012 | Outer Diameter 4.0 mm | In distribution | |
| 3120413 | Length 13.0 mm | In distribution | |
| 876-753 | Length 13.0 mm | In distribution | |
| 6190035 | In distribution | ||
| X0607187 | Width 100.0 mm | In distribution | |
| 6190065 | 65mm | In distribution | |
| 7200047 | In distribution | ||
| 6190072 | In distribution | ||
| 876-175 | Width 75.0 mm | In distribution | |
| X0607180 | Width 62.5 mm | In distribution | |
| X1107033 | Length 13.0 mm | In distribution | |
| 3125313 | Length 13.0 mm | In distribution | |
| 7200085 | Width 85.0 mm | In distribution | |
| 876-121 | Width 21.0 mm | In distribution | |
| 976-195 | Width 95.0 mm | In distribution | |
| 3120314 | In distribution | ||
| 6190027 | 27.5mm | In distribution | |
| X0512091 | Outer Diameter 4.5 mm | In distribution | |
| 3120513S | Outer Diameter 4.0 mm | 2 | In distribution |
| 976-190 | Width 90.0 mm | In distribution | |
| X0506256 | 22mm x 13mm | In distribution | |
| 3120214 | In distribution | ||
| 7200087 | In distribution | ||
| 3120316 | In distribution | ||
| 3120417 | In distribution | ||
| 976-185 | Width 85.0 mm | In distribution | |
| 3120515 | Length 15.0 mm | In distribution | |
| 7200147 | In distribution | ||
| 876-612 | Outer Diameter 4.0 mm | In distribution | |
| X876-822 | Length 22.0 mm | In distribution | |
| 6190019 | In distribution | ||
| 3120220 | In distribution | ||
| 6190080 | In distribution | ||
| 976-165 | Width 65.0 mm | In distribution | |
| 7200067 | Width 67.5 mm | In distribution | |
| 3125315 | Length 15.0 mm | In distribution | |
| 876-015 | Length 15.0 mm | In distribution | |
| 6190055 | In distribution | ||
| 876-316 | Outer Diameter 4.0 mm | In distribution | |
| 3120420 | Outer Diameter 4.0 mm | In distribution | |
| 6190032 | 32.5mm | In distribution | |
| 7200035 | In distribution | ||
| 6190067 | 67.5mm | In distribution | |
| 7200070 | Width 70.0 mm | In distribution | |
| 7200075 | Width 75.0 mm | In distribution | |
| 876-157 | Width 57.5 mm | In distribution | |
| 876-137 | Width 37.5 mm | In distribution | |
| X0109238 | Width 35.0 mm | In distribution | |
| 7200055 | In distribution | ||
| 876-018 | Length 18.0 mm | In distribution | |
| 6190075 | In distribution | ||
| 3120317 | Length 17.0 mm | In distribution | |
| 3125415 | Outer Diameter 4.5 mm | In distribution | |
| 3120514 | Length 14.0 mm | In distribution | |
| 3125211 | Outer Diameter 4.5 mm | In distribution | |
| 7200127 | In distribution | ||
| 876-717 | Length 17.0 mm | In distribution | |
| 3120415 | Length 15.0 mm | In distribution | |
| 876-755 | Length 15.0 mm | In distribution | |
| 6190025 | 25mm | In distribution | |
| 3125313 | In distribution | ||
| 876-185 | Width 85.0 mm | In distribution | |
| 7200072 | In distribution | ||
| 3120213 | Length 13.0 mm | In distribution | |
| 3125317 | In distribution | ||
| X876-858 | Outer Diameter 4.5 mm | In distribution | |
| 876-711 | Outer Diameter 4.0 mm | In distribution | |
| 6190021 | Width 21.0 mm | In distribution | |
| 3120313 | In distribution | ||
| 7200155 | In distribution | ||
| 976-645 | Length 15.0 mm | In distribution | |
| 3125215 | Outer Diameter 4.5 mm | In distribution | |
| 7200032 | In distribution | ||
| 6190075 | 75mm | In distribution | |
| 3120215 | In distribution | ||
| 876-318 | Length 18.0 mm | In distribution | |
| X876-620 | Length 20.0 mm | In distribution | |
| 7200087 | Width 87.5 mm | In distribution | |
| 6190050 | In distribution | ||
| 876-016 | Length 16.0 mm | In distribution | |
| 876-714 | Length 14.0 mm | In distribution | |
| 7200057 | Width 57.5 mm | In distribution | |
| 6190050 | 50mm | In distribution | |
| 3125315 | In distribution | ||
| 876-319 | Length 19.0 mm | In distribution | |
| 7200082 | In distribution | ||
| 3120417 | Outer Diameter 4.0 mm | In distribution | |
| 7200167 | Width 67.5 mm | In distribution | |
| 6190082 | In distribution | ||
| 7200080 | Width 80.0 mm | In distribution | |
| 3120516 | In distribution | ||
| 3125417 | Outer Diameter 4.5 mm | In distribution | |
| X876-157 | Width 57.5 mm | In distribution | |
| 3120316 | Outer Diameter 4.0 mm | In distribution | |
| 3120520 | Length 20.0 mm | In distribution | |
| X0607177 | Width 37.5 mm | In distribution | |
| 3120419 | Outer Diameter 4.0 mm | In distribution | |
| 7200065 | In distribution | ||
| 876-142 | Width 42.5 mm | In distribution | |
| 7200090 | In distribution | ||
| 876-811 | Outer Diameter 4.0 mm | In distribution | |
| 7200105 | In distribution | ||
| X0607188 | Width 85.0 mm | In distribution | |
| X0607176 | Width 35.0 mm | In distribution | |
| X876-762 | Length 22.0 mm | In distribution | |
| 3120318 | In distribution | ||
| 7200170 | In distribution | ||
| X0607175 | Width 32.5 mm | In distribution | |
| 7200127 | Width 27.5 mm | In distribution | |
| 976-127 | Width 27.5 mm | In distribution | |
| X1107035 | Outer Diameter 4.25 mm | In distribution | |
| 7200082 | Width 82.5 mm | In distribution | |
| X0109237 | Width 32.5 mm | In distribution | |
| 3125311 | Length 11.0 mm | In distribution | |
| 6190062 | In distribution | ||
| 976-200 | Width 100.0 mm | In distribution | |
| 7200182 | Width 82.5 mm | In distribution | |
| 876-810 | Length 10.0 mm | In distribution | |
| 7200152 | In distribution | ||
| X876-824 | Length 24.0 mm | In distribution | |
| 876-817 | Length 17.0 mm | In distribution | |
| 3120411 | In distribution | ||
| X0512087 | Length 14.0 mm | In distribution | |
| 876-644 | Outer Diameter 4.5 mm | In distribution | |
| 876-818 | Outer Diameter 4.0 mm | In distribution | |
| 3120315S | Length 15.0 mm | 2 | In distribution |
| 7200021S | Width 21.0 mm | In distribution | |
| 876-814 | Length 14.0 mm | In distribution | |
| 3125411 | Length 11.0 mm | In distribution | |
| 6190032 | In distribution | ||
| 3125413 | In distribution | ||
| X0109234 | Width 25.0 mm | In distribution | |
| 3120312 | Outer Diameter 4.0 mm | In distribution | |
| 7200172 | Width 72.5 mm | In distribution | |
| 7200182 | In distribution | ||
| 3120313 | Length 13.0 mm | In distribution | |
| 7200070 | In distribution | ||
| 7200050 | Width 50.0 mm | In distribution | |
| 976-152 | Width 52.5 mm | In distribution | |
| 976-643 | Outer Diameter 4.5 mm | In distribution | |
| X876-760 | Outer Diameter 4.5 mm | In distribution | |
| 876-020 | Outer Diameter 4.0 mm | In distribution | |
| 876-011 | Length 11.0 mm | In distribution | |
| 876-010 | Outer Diameter 4.0 mm | In distribution | |
| X0109231 | Width 19.0 mm | In distribution | |
| 7200155 | Width 55.0 mm | In distribution | |
| 3125517 | In distribution | ||
| 3120412 | In distribution | ||
| 876-200 | Width 100.0 mm | In distribution | |
| 7200042 | In distribution | ||
| X876-616 | Outer Diameter 4.0 mm | In distribution | |
| 3125411 | In distribution | ||
| 3120212 | In distribution | ||
| 7200030 | Width 30.0 mm | In distribution | |
| 6190025 | In distribution | ||
| 3120319 | Length 19.0 mm | In distribution | |
| 7200060 | Width 60.0 mm | In distribution | |
| X1107032 | Length 12.0 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| ev3, Inc. | UDI-DI | 2021-03-23 | Class III | Device Design | Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter. | 154,152 units | 2026-08-04 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2012-08-30 | Class II | Nonconforming Material/Component | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. | 1047 units | 2013-08-15 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2012-08-30 | Class II | Nonconforming Material/Component | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. | 1014 units | 2013-08-15 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2012-08-30 | Class II | Nonconforming Material/Component | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. | 247 units | 2013-08-15 |
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.