CD Horizon® Spinal System
Screw 25530011250 BS Cncmas 12.5X50 TC S
11manufacturers in China registered for this device type
3,188catalogue numbers in this listing
44510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K153442 |
| Record published | 2016-04-08 |
| Record revised | 2022-09-16 (version 10) |
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 |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 5.5 to 500 mm; outer diameter 3.5 to 45 mm; circumference 5.5 to 6 mm; height 3 to 38 mm; width 4.75 to 6.35 mm; length 4 to 20 cm; angle 75 °; length 1.55 to 1.75 in |
| Distribution end date | 2026-01-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25530011250 | In distribution | |
| 75698525 | Outer Diameter 8.5 mm | In distribution |
| X0808087 | Outer Diameter 5.5 mm | In distribution |
| X0809518 | Length 95.0 mm | In distribution |
| 5932100332 | In distribution | |
| 99417540 | Length 40.0 mm | In distribution |
| 25100105 | In distribution | |
| X1010510 | In distribution | |
| 55811015035 | Outer Diameter 5.0 mm | In distribution |
| 55740004015 | 4.0 X 15 mm | In distribution |
| 7663640 | In distribution | |
| X0710986 | In distribution | |
| X1013200 | 9.0mm | In distribution |
| 7661198 | In distribution | |
| X0311110 | In distribution | |
| 55740009030 | 9.0 X 30 mm | In distribution |
| X0909446 | Length 35.0 mm | In distribution |
| X0311045 | In distribution | |
| 54740106530 | Outer Diameter 6.5 mm | In distribution |
| 75494535 | Outer Diameter 4.5 mm | In distribution |
| X06123805 | Length 35.0 mm | In distribution |
| 75448545 | Outer Diameter 8.5 mm | In distribution |
| 7642435 | In distribution | |
| G8115522 | 22mm | In distribution |
| X1010414 | In distribution | |
| 55811018575 | Outer Diameter 8.5 mm | In distribution |
| 1554300500 | Outer Diameter 5.5 mm | In distribution |
| X1010505 | In distribution | |
| X0711011 | In distribution | |
| X0808088 | Outer Diameter 5.5 mm | In distribution |
| X0812145 | Length 55.0 mm | In distribution |
| X1010459 | In distribution | |
| 55840004045 | Length 45.0 mm | In distribution |
| X0612682 | Length 60.0 mm | In distribution |
| X1010700 | Outer Diameter 6.5 mm | In distribution |
| 7041790 | Length 90.0 mm | In distribution |
| 55740007530 | 7.5 X 30 mm | In distribution |
| 5542326 | In distribution | |
| 76446530 | In distribution | |
| 8115516 | Length 16.0 mm | In distribution |
| 54740109540 | Length 40.0 mm | In distribution |
| 7041745 | Outer Diameter 7.5 mm | In distribution |
| X0410398 | Outer Diameter 4.5 mm | In distribution |
| X0411226 | Outer Diameter 5.5 mm | In distribution |
| 1555101070 | Outer Diameter 5.5 mm | In distribution |
| X0311044 | In distribution | |
| 75695525 | Outer Diameter 5.5 mm | In distribution |
| 75454045 | Outer Diameter 4.0 mm | In distribution |
| X0212587 | 7.5mm x 40mm | In distribution |
| 55900005540 | In distribution | |
| X0212319 | Length 85.0 mm | In distribution |
| 651101190 | Outer Diameter 5.5 mm | In distribution |
| X0311097 | In distribution | |
| X0902309 | In distribution | |
| 1553301030 | Outer Diameter 5.5 mm | In distribution |
| 96018HT | In distribution | |
| X06123210 | Length 70.0 mm | In distribution |
| X70258550 | In distribution | |
| X0602551L | In distribution | |
| X1010502 | In distribution | |
| 55890006080 | Outer Diameter 6.0 mm | In distribution |
| 55410005025 | Outer Diameter 5.0 mm | In distribution |
| 55410007535 | Length 35.0 mm | In distribution |
| X0911241 | Length 60.0 mm | In distribution |
| X1010503 | In distribution | |
| X06123682 | Length 60.0 mm | In distribution |
| 1476006460 | Length 460.0 mm | In distribution |
| 652101110 | Length 110.0 mm | In distribution |
| 8699100 | In distribution | |
| X0708347 | Length 55.0 mm | In distribution |
| X0809490 | Length 40.0 mm | In distribution |
| X0212685 | Length 100.0 mm | In distribution |
| X1010453 | In distribution | |
| 25740019580 | In distribution | |
| 55890006075 | Length 75.0 mm | In distribution |
| X0311324 | Length 95.0 mm | In distribution |
| 7561174 | Large | In distribution |
| X0902005 | 23mm | In distribution |
| 86945535 | Length 35.0 mm | In distribution |
| X0410397 | Outer Diameter 4.5 mm | In distribution |
| 5441196 | Small | In distribution |
| 7561114 | Large | In distribution |
| 55740006015 | 6.0 X 15 mm | In distribution |
| 7041460 | Length 60.0 mm | In distribution |
| X1009483 | Length 75.0 mm | In distribution |
| X06123332 | Length 45.0 mm | In distribution |
| 7541114 | Large | In distribution |
| 55740005060 | 5.0 X 60 mm | In distribution |
| 55811008585 | Length 85.0 mm | In distribution |
| 7641174 | In distribution | |
| 55811017020 | Outer Diameter 7.0 mm | In distribution |
| 7022855 | Outer Diameter 8.5 mm | In distribution |
| 5932100330 | In distribution | |
| 7197545 | Outer Diameter 7.5 mm | In distribution |
| 7577550 | In distribution | |
| 7643555 | In distribution | |
| 74646050 | Length 50.0 mm | In distribution |
| 7462550 | Length 50.0 mm | In distribution |
| 7563425 | D-Diameter 4.5MM | In distribution |
| 5553255 | 5.5-6.0MM | In distribution |
| X0612316 | Length 25.0 mm | In distribution |
| X0812053 | Length 15.0 mm | In distribution |
| 75496555 | Outer Diameter 6.5 mm | In distribution |
| X1010467 | In distribution | |
| 75656045 | Outer Diameter 6.0 mm | In distribution |
| 54740106560 | Length 60.0 mm | In distribution |
| X0610036 | In distribution | |
| 55811008535 | Length 35.0 mm | In distribution |
| X0809476 | Length 55.0 mm | In distribution |
| X1010617 | Outer Diameter 4.0 mm | In distribution |
| 1555501080 | Length 80.0 mm | In distribution |
| 75464515 | Length 15.0 mm | In distribution |
| 7661122 | In distribution | |
| 75695545 | Outer Diameter 5.5 mm | In distribution |
| X0404550R | Small | In distribution |
| X0509155 | Length 30 to 34MM | In distribution |
| 55811009550 | Length 50.0 mm | In distribution |
| X0911140 | Length 90.0 mm | In distribution |
| X0703011R | In distribution | |
| 55740108545 | Length 45.0 mm | In distribution |
| 86947535 | Length 35.0 mm | In distribution |
| X0612405 | Length 20.0 mm | In distribution |
| X0311146 | In distribution | |
| X0411434 | Length 30.0 mm | In distribution |
| 76445025 | In distribution | |
| X0212280 | Length 15.0 mm | In distribution |
| 5441103 | Medium | In distribution |
| X1010715 | Length 35.0 mm | In distribution |
| 7541343 | Medium | In distribution |
| X0808111 | Length 45.0 mm | In distribution |
| 778244545 | In distribution | |
| 55890008560 | Length 60.0 mm | In distribution |
| X09103488 | In distribution | |
| 7221850 | Outer Diameter 8.5 mm | In distribution |
| X02121112 | Length 25.0 mm | In distribution |
| 7663540 | In distribution | |
| 75498550 | Outer Diameter 8.5 mm | In distribution |
| 859-630 | Length 30.0 mm | In distribution |
| 76496555 | In distribution | |
| 76444550 | In distribution | |
| G5932004747 | In distribution | |
| 1555006350 | Length 350.0 mm | In distribution |
| 859-002 | In distribution | |
| 1556006460 | Length 460.0 mm | In distribution |
| X0212284 | Length 75.0 mm | In distribution |
| 651101055 | Length 55.0 mm | In distribution |
| X0711375 | Outer Diameter 9.5 mm | In distribution |
| X0808124 | Length 60.0 mm | In distribution |
| X0710039 | Length 40.0 mm | In distribution |
| X0311096 | In distribution | |
| 74644040 | Length 40.0 mm | In distribution |
| X1209874 | In distribution | |
| X0312271 | Length 50.0 mm | In distribution |
| 7892860 | Length 60.0 mm | In distribution |
| X0809464 | Length 80.0 mm | In distribution |
| 6902200 | In distribution | |
| 7221660 | Outer Diameter 6.5 mm | In distribution |
| X0110298 | Outer Diameter 4.5 mm | In distribution |
| 99417545 | Length 45.0 mm | In distribution |
| X0812240 | Length 75.0 mm | In distribution |
| 7561188 | In distribution | |
| 8690100 | Length 100.0 mm | In distribution |
| X1010411 | In distribution | |
| 7576565 | In distribution | |
| 75695025 | Outer Diameter 5.0 mm | In distribution |
| 55740005525 | 5.5 X 25 mm | In distribution |
| 54740107050 | Outer Diameter 7.0 mm | In distribution |
| 1605006190 | Length 190.0 mm | In distribution |
| X0212337 | Length 90.0 mm | In distribution |
| 55890007500 | Outer Diameter 7.5 mm | In distribution |
| 75657530 | Outer Diameter 7.5 mm | In distribution |
| 55740005015 | 5.0 X 15 mm | In distribution |
| 75694530 | Outer Diameter 30.0 mm | In distribution |
| 7021800 | Outer Diameter 8.5 mm | In distribution |
| X02121203 | Length 80.0 mm | In distribution |
| X0811196 | Length 50.0 mm | In distribution |
| 5484805 | In distribution | |
| X1010708 | Length 85.0 mm | In distribution |
| X02121073 | Length 70.0 mm | In distribution |
| X0612475 | Outer Diameter 7.5 mm | In distribution |
| X0410392 | Outer Diameter 4.0 mm | In distribution |
| X0808222 | Outer Diameter 6.0 mm | In distribution |
| 55890009025 | Outer Diameter 9.0 mm | In distribution |
| X0209253 | In distribution | |
| X0809469 | Length 20.0 mm | In distribution |
| X0311157 | In distribution | |
| X0909470 | Length 70.0 mm | In distribution |
| X0809181 | Length 25.0 mm | In distribution |
| 96505HT | In distribution | |
| 7462440 | Outer Diameter 4.0 mm | In distribution |
| X1010580 | In distribution | |
| X0809516 | Length 85.0 mm | In distribution |
| 76446550 | In distribution | |
| X0612484 | Outer Diameter 8.0 mm | In distribution |
| X0212614 | Length 80.0 mm | In distribution |
| 7191660 | Outer Diameter 6.5 mm | In distribution |
| 1555501075 | Length 75.0 mm | In distribution |
| X06123667 | Length 65.0 mm | In distribution |
| 1555006270 | Length 270.0 mm | In distribution |
| X0911125 | Length 55.0 mm | In distribution |
| X06123225 | Length 65.0 mm | In distribution |
| X0612679 | Length 45.0 mm | In distribution |
| X0313388 | 4.5mm Side / 4.5mm Closed | In distribution |
| X0212356 | Length 60.0 mm | In distribution |
| X0411435 | Length 35.0 mm | In distribution |
| X0612513 | Outer Diameter 8.5 mm | In distribution |
| 25840019590 | In distribution | |
| X02121004 | Length 45.0 mm | In distribution |
| 5443225 | Length 25.0 mm | In distribution |
| 7441122 | In distribution | |
| 99460065 | 6.5cm | In distribution |
| 54740046550 | Outer Diameter 6.5 mm | In distribution |
| 5440420 | In distribution | |
| X0708366 | Outer Diameter 7.5 mm | In distribution |
| 6541125 | In distribution | |
| X0511024 | Outer Diameter 6.5 mm | In distribution |
| 8672110 | In distribution | |
| 55410005520 | Length 20.0 mm | In distribution |
| 75455045 | Outer Diameter 5.0 mm | In distribution |
| X0909481 | Length 40.0 mm | In distribution |
| X70258590 | In distribution | |
| X0909386 | Length 75.0 mm | In distribution |
| 778145555 | In distribution | |
| 7040560 | Length 60.0 mm | In distribution |
| X0812146 | Length 60.0 mm | In distribution |
| 1555501055 | Length 55.0 mm | In distribution |
| 8698050 | Length 50.0 mm | In distribution |
| 1554006370 | Length 370.0 mm | In distribution |
| 5553265 | Length 65.0 mm | In distribution |
| 55410006580 | Length 80.0 mm | In distribution |
| 7574575 | In distribution | |
| 1555006390 | Length 390.0 mm | In distribution |
| 7541198 | In distribution | |
| 5932160339 | In distribution | |
| 7461198 | In distribution | |
| X0809412 | Outer Diameter 5.5 mm | In distribution |
| X06123178 | Length 50.0 mm | In distribution |
| X0311160 | In distribution | |
| X0411246 | Outer Diameter 7.5 mm | In distribution |
| 76696540 | Length 40.0 mm | In distribution |
| 86946530 | Length 30.0 mm | In distribution |
| 7643670 | Length 70.0 mm | In distribution |
| 7020840 | Length 40.0 mm | In distribution |
| 1556006470 | Length 470.0 mm | In distribution |
| 8698095 | Length 95.0 mm | In distribution |
| X0107050 | Length 50.0 mm | In distribution |
| X0313384 | 5.5mm Side / 6.35mm Closed | In distribution |
| 55811005065 | Outer Diameter 5.0 mm | In distribution |
| G8690060 | Length 60.0 mm | In distribution |
| 55840006525 | Outer Diameter 6.5 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
| Vertex® Reconstruction System | Medtronic Sofamor Danek, Inc. | 830 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121191 | 2012-06-29 |
| K102886 | 2011-01-26 |
| K090714 | 2009-04-17 |
| K083071 | 2008-11-14 |
| K081297 | 2008-06-11 |
| K080805 | 2008-04-18 |
| K071942 | 2007-12-11 |
| K062447 | 2007-10-15 |
| K070742 | 2007-09-14 |
| K061591 | 2006-09-08 |
| K061579 | 2006-08-11 |
| K060081 | 2006-02-13 |
| K052734 | 2005-10-21 |
| K052376 | 2005-09-23 |
| K052402 | 2005-09-23 |
| K052180 | 2005-08-23 |
| K050484 | 2005-05-04 |
| K043053 | 2005-04-11 |
| K043020 | 2005-01-07 |
| K042789 | 2004-12-21 |
| K042524 | 2004-10-08 |
| K042498 | 2004-10-07 |
| K042402 | 2004-10-01 |
| K041862 | 2004-09-15 |
| K041282 | 2004-06-10 |
| K030875 | 2003-06-24 |
| K031533 | 2003-06-13 |
| K030816 | 2003-06-06 |
| K023415 | 2002-12-13 |
| K023797 | 2002-12-13 |
| K014296 | 2002-12-10 |
| K023555 | 2002-11-22 |
| K022191 | 2002-08-28 |
| K021061 | 2002-07-25 |
| K022070 | 2002-07-22 |
| K022015 | 2002-07-18 |
| K020709 | 2002-05-09 |
| K020426 | 2002-02-26 |
| K020155 | 2002-02-05 |
| K014267 | 2002-01-25 |
| K003780 | 2001-09-28 |
| K011508 | 2001-06-12 |
| K010181 | 2001-06-12 |
| K001532 | 2000-06-16 |
Recalls Naming This Product
9 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 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2007-08-24 | Not classified | Device Design | Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws. | 20 units | 2009-08-21 |
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.