CD Horizon® Spinal System
Screw X0909476 LEG 6.35 Ogthn TI 6.5X100
14manufacturers in China registered for this device type
2,568catalogue 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) | K040583 |
| Record published | 2015-06-19 |
| Record revised | 2025-12-23 (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 5.5 to 650 mm; outer diameter 3.5 to 32 mm; height 4.75 to 26 mm; width 4.75 to 6.35 mm; circumference 5.5 to 6 mm; length 4 to 19 cm; angle 75 °; length 0.5 to 6.1 in |
| Distribution end date | 2026-01-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7643560 | In distribution | |
| 76697550 | Outer Diameter 7.5 mm | In distribution |
| 54840018045 | Outer Diameter 8.45 mm | In distribution |
| X0710928 | In distribution | |
| 55740005080 | 5.0 X 80 mm | In distribution |
| X0810623 | Outer Diameter 5.5 mm | In distribution |
| 55840016555 | Length 55.0 mm | In distribution |
| X0909476 | Length 100.0 mm | In distribution |
| X0409381 | In distribution | |
| 75454030 | Outer Diameter 4.0 mm | In distribution |
| 54740044525 | Length 25.0 mm | In distribution |
| X0708356 | Outer Diameter 6.5 mm | In distribution |
| X0312270 | Length 45.0 mm | In distribution |
| 76644545 | In distribution | |
| 55890005055 | Outer Diameter 5.0 mm | In distribution |
| X0911113 | Length 25.0 mm | In distribution |
| 55740009590 | 9.5 X 90 mm | In distribution |
| X0710940 | In distribution | |
| 75695530 | Outer Diameter 5.5 mm | In distribution |
| X0311338 | Length 100.0 mm | In distribution |
| 75454530 | Outer Diameter 4.5 mm | In distribution |
| 662101075 | Length 75.0 mm | In distribution |
| 7562640 | D-Diameter 6MM | In distribution |
| X06123784 | Length 15.0 mm | In distribution |
| X0312403 | 9.0mm x 70mm | In distribution |
| X0212510 | Length 20.0 mm | In distribution |
| X050710321 | Outer Diameter 21.0 mm | In distribution |
| X1110124 | In distribution | |
| X02121144 | Length 25.0 mm | In distribution |
| 55890007065 | Length 65.0 mm | In distribution |
| X0811188 | Length 70.0 mm | In distribution |
| 54840004555 | Length 55.0 mm | In distribution |
| 5932100301 | In distribution | |
| 7198550 | Outer Diameter 8.5 mm | In distribution |
| 54840007530 | Outer Diameter 7.5 mm | In distribution |
| X1010623 | Outer Diameter 4.0 mm | In distribution |
| X0311153 | In distribution | |
| 55840006555 | Length 55.0 mm | In distribution |
| X0809237 | Length 30.0 mm | In distribution |
| 55890009580 | Outer Diameter 9.5 mm | In distribution |
| X0710989 | In distribution | |
| X06123737 | Length 65.0 mm | In distribution |
| 7563540 | DIA-Diameter 5.5MM | In distribution |
| 7892540 | Length 40.0 mm | In distribution |
| X0711384 | Outer Diameter 9.5 mm | In distribution |
| 8540615 | Rod Span 15MM | In distribution |
| X0909479 | Length 30.0 mm | In distribution |
| 55840018540 | Outer Diameter 8.5 mm | In distribution |
| 7191750 | Length 50.0 mm | In distribution |
| 778125565 | In distribution | |
| X0309088 | Length 75.0 mm | In distribution |
| 55410006025 | Outer Diameter 6.0 mm | In distribution |
| 75645550 | Outer Diameter 5.5 mm | In distribution |
| X06123286 | Length 100.0 mm | In distribution |
| X0208097 | Outer Diameter 11.5 mm | In distribution |
| 7571180 | Outer Diameter 5.5 mm | In distribution |
| 7571360 | Outer Diameter 5.5 mm | In distribution |
| X0208307 | Length 40.0 mm | In distribution |
| 858-855 | In distribution | |
| 55840018075 | Outer Diameter 8.0 mm | In distribution |
| 55811007550 | Length 50.0 mm | In distribution |
| X0612620 | 6.0mm x 75mm | In distribution |
| X0407327 | Outer Diameter 8.5 mm | In distribution |
| 86992445 | Length 45.0 mm | In distribution |
| Y7556555 | Outer Diameter 6.5 mm | In distribution |
| 55740009060 | 9.0 X 60 mm | In distribution |
| 54840018595 | Outer Diameter 8.5 mm | In distribution |
| X0808241 | Length 30.0 mm | In distribution |
| X0909512 | Length 25.0 mm | In distribution |
| 55840004075 | Outer Diameter 4.0 mm | In distribution |
| 55811017080 | Length 80.0 mm | In distribution |
| 1556006310 | Length 310.0 mm | In distribution |
| 6641040 | Outer Diameter 4.0 mm | In distribution |
| 651001045 | Outer Diameter 5.5 mm | In distribution |
| X0411236 | Length 80.0 mm | In distribution |
| 55840019570 | Outer Diameter 9.5 mm | In distribution |
| 55840014565 | Outer Diameter 4.5 mm | In distribution |
| 55840009015 | Outer Diameter 9.0 mm | In distribution |
| 7030655 | Outer Diameter 6.5 mm | In distribution |
| 54840006080 | Outer Diameter 6.0 mm | In distribution |
| 55840018511 | Length 110.0 mm | In distribution |
| 75654540 | Outer Diameter 4.5 mm | In distribution |
| X609712 | In distribution | |
| 8106458 | Length span 58-80MM | In distribution |
| X0909508 | Length 90.0 mm | In distribution |
| 54840019585 | Outer Diameter 9.5 mm | In distribution |
| 55811019515 | Length 15.0 mm | In distribution |
| X06123190 | Length 40.0 mm | In distribution |
| X02121152 | Length 65.0 mm | In distribution |
| 7574535 | In distribution | |
| 55840018515 | Outer Diameter 8.5 mm | In distribution |
| X0710848 | In distribution | |
| 54840017525 | Outer Diameter 7.5 mm | In distribution |
| 7041740 | Length 40.0 mm | In distribution |
| 848-635 | In distribution | |
| 54840017070 | Length 70.0 mm | In distribution |
| 154214260 | In distribution | |
| X0312328 | 7.0mm x 65mm | In distribution |
| 54840018540 | Outer Diameter 8.5 mm | In distribution |
| X0911234 | Length 25.0 mm | In distribution |
| 25530019511 | In distribution | |
| X0999074 | Length 650.0 mm | In distribution |
| X0911027 | Length 35.5 mm | In distribution |
| 858-140 | In distribution | |
| X0909473 | Length 85.0 mm | In distribution |
| 7541223 | In distribution | |
| X0612342 | Length 70.0 mm | In distribution |
| NAV2001 | 4.0MM | In distribution |
| 9690110 | Length 110.0 mm | In distribution |
| 55901006555 | In distribution | |
| X0909537 | Length 65.0 mm | In distribution |
| 76447570 | In distribution | |
| 778244565 | In distribution | |
| X0612356 | Length 25.0 mm | In distribution |
| 5541199 | In distribution | |
| X1010690 | Outer Diameter 6.0 mm | In distribution |
| 662101060 | Outer Diameter 6.0 mm | In distribution |
| X0212388 | Length 110.0 mm | In distribution |
| X02121079 | Length 100.0 mm | In distribution |
| 8570615 | In distribution | |
| 7042410 | Length 35.0 mm | In distribution |
| 7661199 | In distribution | |
| X06123216 | Length 20.0 mm | In distribution |
| 7661222 | In distribution | |
| X0711374 | Length 100.0 mm | In distribution |
| 7573455 | Length 55.0 mm | In distribution |
| X0909467 | Length 55.0 mm | In distribution |
| 70267560 | Outer Diameter 7.5 mm | In distribution |
| 9690050 | Length 50.0 mm | In distribution |
| X0208320 | Outer Diameter 5.5 mm | In distribution |
| 75458535 | Outer Diameter 8.5 mm | In distribution |
| X0909447 | Length 40.0 mm | In distribution |
| 74645550 | Length 50.0 mm | In distribution |
| X1010619 | Length 65.0 mm | In distribution |
| 54740105570 | Length 70.0 mm | In distribution |
| 8672060 | Length 60.0 mm | In distribution |
| 7441199 | In distribution | |
| 55811008015 | Length 15.0 mm | In distribution |
| 9010004075 | Length 75.0 mm | In distribution |
| X1008204 | In distribution | |
| 55740001550 | 10.5 X 50 mm | In distribution |
| X1110121 | In distribution | |
| 55811019040 | Outer Diameter 9.0 mm | In distribution |
| 55840005080 | Outer Diameter 5.0 mm | In distribution |
| 55740105550 | In distribution | |
| X0311062 | In distribution | |
| 8115536 | Length span 36-39MM | In distribution |
| 76646565 | Length 65.0 mm | In distribution |
| X0212403 | Length 90.0 mm | In distribution |
| X06123694 | Length 40.0 mm | In distribution |
| 8549015 | Rod Span 38MM | In distribution |
| 7662455 | In distribution | |
| 74644030 | Length 30.0 mm | In distribution |
| X0612516 | Length 30.0 mm | In distribution |
| 7643640 | In distribution | |
| 7541314 | Large | In distribution |
| X02121207 | Length 100.0 mm | In distribution |
| X02121054 | Length 55.0 mm | In distribution |
| 8540613 | Rod Span 13MM | In distribution |
| X1010637 | Length 70.0 mm | In distribution |
| X1209825 | In distribution | |
| X0212349 | Length 25.0 mm | In distribution |
| 75646560 | Outer Diameter 6.5 mm | In distribution |
| X0207101 | Outer Diameter 7.5 mm | In distribution |
| X06123656 | Length 80.0 mm | In distribution |
| X0911033 | Length 60.0 mm | In distribution |
| 84107DET | In distribution | |
| X1010450 | In distribution | |
| 55811019580 | Length 80.0 mm | In distribution |
| 25530011190 | In distribution | |
| X0812267 | Length 70.0 mm | In distribution |
| 54840044540 | Outer Diameter 4.5 mm | In distribution |
| X70257555 | In distribution | |
| 1606006140 | Length 140.0 mm | In distribution |
| 55840016085 | Length 85.0 mm | In distribution |
| 25630011211 | In distribution | |
| 9010000830 | R=127 | In distribution |
| X1008193 | In distribution | |
| 8672090 | Length 90.0 mm | In distribution |
| 54840005035 | Length 35.0 mm | In distribution |
| X02121147 | Length 40.0 mm | In distribution |
| X06123209 | Length 65.0 mm | In distribution |
| 7463625 | Length 25.0 mm | In distribution |
| 7663530 | In distribution | |
| 5764235 | Length 35.0 mm | In distribution |
| 75655545 | Outer Diameter 5.5 mm | In distribution |
| X06123693 | Length 35.0 mm | In distribution |
| X0808231 | Outer Diameter 7.0 mm | In distribution |
| 55740008020 | 8.0 X 20 mm | In distribution |
| X06123298 | Length 65.0 mm | In distribution |
| X0902310 | In distribution | |
| 7563555 | DIA-Diameter 5.5MM | In distribution |
| X0710960 | Length 25.0 mm | In distribution |
| 70268570 | Outer Diameter 8.5 mm | In distribution |
| 7573765 | Outer Diameter 7.5 mm | In distribution |
| X0809374 | Length 55.0 mm | In distribution |
| 55890009585 | Length 85.0 mm | In distribution |
| 55840016595 | Length 95.0 mm | In distribution |
| 86945565 | Length 5.5 mm | In distribution |
| 8690085 | Length 85.0 mm | In distribution |
| 55811019025 | Length 25.0 mm | In distribution |
| 1554006270 | Length 270.0 mm | In distribution |
| 54840019050 | Length 50.0 mm | In distribution |
| X0810603 | Length 5.5 mm | In distribution |
| X0312412 | 9.5mm x 30mm | In distribution |
| 55740007585 | 7.5 X 85 mm | In distribution |
| 5541342 | Small | In distribution |
| X0811190 | Length 90.0 mm | In distribution |
| X0809474 | Length 45.0 mm | In distribution |
| X1010550 | In distribution | |
| 778116565 | In distribution | |
| X8674540 | Length 40.0 mm | In distribution |
| X0209246 | Length 25.0 mm | In distribution |
| 55890006520 | Outer Diameter 6.5 mm | In distribution |
| X1010586 | In distribution | |
| X02121136 | Length 65.0 mm | In distribution |
| X0612396 | Length 45.0 mm | In distribution |
| 75455020 | Outer Diameter 5.0 mm | In distribution |
| X0909472 | Length 80.0 mm | In distribution |
| X70255560 | In distribution | |
| 7641173 | In distribution | |
| X0809113 | Outer Diameter 6.5 mm | In distribution |
| 25840011060 | In distribution | |
| X1010614 | Length 40.0 mm | In distribution |
| 54840005525 | Outer Diameter 5.5 mm | In distribution |
| 55740001575 | 10.5 X 75 mm | In distribution |
| 651101030 | Length 30.0 mm | In distribution |
| 55410004555 | Length 55.0 mm | In distribution |
| X06123748 | Length 25.0 mm | In distribution |
| 55840017585 | Length 85.0 mm | In distribution |
| 54840008500 | Outer Diameter 8.5 mm | In distribution |
| 7191765 | Outer Diameter 7.5 mm | In distribution |
| 55840019525 | Length 25.0 mm | In distribution |
| Y7556550 | Length 50.0 mm | In distribution |
| X0709136 | Length 90.0 mm | In distribution |
| 55840005070 | Length 70.0 mm | In distribution |
| X1010434 | In distribution | |
| 54740109555 | Length 55.0 mm | In distribution |
| 8549018 | Rod span-large | In distribution |
| 8106434 | Length span 34-36MM | In distribution |
| 8115545 | Length span 45-58MM | In distribution |
| X0210272 | Length 65.0 mm | In distribution |
| 55740008530 | 8.5 X 30 mm | In distribution |
| X0809151 | Length 30.0 mm | In distribution |
| X0809372 | Outer Diameter 4.5 mm | In distribution |
| X0710898 | In distribution | |
| 55840008565 | Outer Diameter 8.5 mm | In distribution |
| 86947555 | Length 55.0 mm | In distribution |
| 76497545 | In distribution | |
| X84505LHT | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| 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 |
| CastleLoc-P Anterior Cervical Plate System | L&K Biomed Co., Ltd. | 873 |
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
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-07-12 | Class II | Under Investigation by firm | Incorrect Laser Marking – Solera Awl Tip Tap | 13 devices | |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2018-07-09 | Class II | Employee error | This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm di | 47 units | 2021-05-07 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2011-11-30 | Not classified | Mixed-up of materials/components | One screw may be longer then size etched on the screw. | 252 units | 2012-04-05 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2011-11-30 | Not classified | Mixed-up of materials/components | One screw may be longer then size etched on the screw. | 30 units | 2012-04-05 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2011-06-28 | Not classified | Other | Screws are longer then size etched on the screw. | 36 units | 2012-12-24 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2011-06-28 | Not classified | Other | Screws are longer then size etched on the screw. | 199 units | 2012-12-24 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2011-06-28 | Not classified | Other | Screws are longer then size etched on the screw. | 29 units | 2012-12-24 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2011-06-28 | Not classified | Other | Screws are longer then size etched on the screw. | 101 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.