CD Horizon® Spinal System
SCR X06123850 5.5-6.0 STH RED MAS 10X110
15manufacturers in China registered for this device type
1,462catalogue numbers in this listing
50510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K201407 |
| Record published | 2020-10-24 |
| 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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 4.5 to 700 mm; outer diameter 3.5 to 40 mm; width 4.75 to 7 mm; height 4.75 to 32 mm; length 3 to 24 cm; circumference 5.5 to 6 mm; angle 75 to 105 °; length 6.25 to 18.137 in |
| Distribution end date | 2026-01-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 55840019550 | Length 50.0 mm | In distribution | |
| X0612531 | Outer Diameter 9.0 mm | In distribution | |
| 778124545 | In distribution | ||
| X06123850 | Length 110.0 mm | In distribution | |
| X0612609 | 6.0mm x 20mm | In distribution | |
| 55840015550 | Length 50.0 mm | In distribution | |
| 859-525 | Length 25.0 mm | In distribution | |
| 859-130 | Width 5.0 mm | In distribution | |
| X0812098 | Length 90.0 mm | In distribution | |
| 1605100500 | Length 500.0 mm | In distribution | |
| 54840004035 | Length 35.0 mm | In distribution | |
| 7221825 | Outer Diameter 8.5 mm | In distribution | |
| 778225555 | In distribution | ||
| 9010000812 | In distribution | ||
| 7224535 | Length 35.0 mm | In distribution | |
| 778246555 | In distribution | ||
| X06123310 | Length 30.0 mm | In distribution | |
| 25630011160 | In distribution | ||
| 5932100000 | In distribution | ||
| 859-152 | In distribution | ||
| 55410006040 | Length 40.0 mm | In distribution | |
| 74445035 | Length 35.0 mm | In distribution | |
| 778164065 | Length 40.0 mm | In distribution | |
| 7578555 | Outer Diameter 8.5 mm | In distribution | |
| 6543630 | Outer Diameter 6.5 mm | In distribution | |
| 54740108030 | Outer Diameter 8.0 mm | In distribution | |
| 55840016011 | Outer Diameter 6.0 mm | In distribution | |
| 662001100 | Outer Diameter 6.0 mm | In distribution | |
| 7641163 | In distribution | ||
| 54840017511 | Outer Diameter 7.5 mm | In distribution | |
| 559200079 | 2 | In distribution | |
| 74446545 | Outer Diameter 6.5 mm | In distribution | |
| 55740005025 | 5.0 X 25 mm | In distribution | |
| X06123237 | Length 45.0 mm | In distribution | |
| 55740009585 | 9.5 X 85 mm | In distribution | |
| 7191665 | Outer Diameter 6.5 mm | In distribution | |
| 55890009030 | Length 30.0 mm | In distribution | |
| 55840014545 | Length 45.0 mm | In distribution | |
| 5541104 | Large | In distribution | |
| X0410389 | Length 30.0 mm | In distribution | |
| X0812101 | Length 25.0 mm | In distribution | |
| X0909345 | Length 30.0 mm | In distribution | |
| 55740005540 | 5.5 X 40 mm | In distribution | |
| 55410006565 | Outer Diameter 6.5 mm | In distribution | |
| 55840011055 | Length 55.0 mm | In distribution | |
| 86992435 | Length 35.0 mm | In distribution | |
| X0612476 | Outer Diameter 7.5 mm | In distribution | |
| 25630019510 | In distribution | ||
| X06123211 | Length 75.0 mm | In distribution | |
| X0212294 | Length 65.0 mm | In distribution | |
| X0312303 | Length 35.0 mm | In distribution | |
| X0612604 | 5.5mm x 65mm | In distribution | |
| 55890008595 | Length 95.0 mm | In distribution | |
| X0212304 | Length 80.0 mm | In distribution | |
| X0212571 | Length 55.0 mm | In distribution | |
| X0212632 | Length 75.0 mm | In distribution | |
| 55840009565 | Length 65.0 mm | In distribution | |
| 86992635 | Length 35.0 mm | In distribution | |
| X0812123 | Length 40.0 mm | In distribution | |
| X0812122 | Length 35.0 mm | In distribution | |
| X0612388 | Length 100.0 mm | In distribution | |
| 1476006290 | Length 290.0 mm | In distribution | |
| 55811019555 | Outer Diameter 9.5 mm | In distribution | |
| 54740109590 | Outer Diameter 9.5 mm | In distribution | |
| 7643745 | In distribution | ||
| 54840005080 | Outer Diameter 5.5 mm | In distribution | |
| 1475006380 | Length 380.0 mm | In distribution | |
| X0312262 | Length 85.0 mm | In distribution | |
| 54740106520 | Outer Diameter 6.5 mm | In distribution | |
| 156214260 | In distribution | ||
| 55900006555 | In distribution | ||
| 652101100 | Outer Diameter 5.5 mm | In distribution | |
| 55740004060 | 4.0 X 60 mm | In distribution | |
| NAV2024 | In distribution | ||
| 1553301080 | Outer Diameter 5.5 mm | In distribution | |
| X06123752 | Length 45.0 mm | In distribution | |
| 55740007540 | 7.5 X 40 mm | In distribution | |
| X0812274 | Length 110.0 mm | In distribution | |
| X0809339 | Length 90.0 mm | In distribution | |
| 7020780 | Outer Diameter 7.5 mm | In distribution | |
| 1555101030 | Length 30.0 mm | In distribution | |
| 1476006250 | Length 250.0 mm | In distribution | |
| X0811212 | Length 110.0 mm | In distribution | |
| 55740005070 | 5.0 X 70 mm | In distribution | |
| 9010014626 | DIA=5.5mm x ML=12.8mm | In distribution | |
| 7021870 | Length 70.0 mm | In distribution | |
| 1475001035 | Length 35.0 mm | In distribution | |
| 55890007015 | Length 15.0 mm | In distribution | |
| 75464020 | Outer Diameter 4.0 mm | In distribution | |
| X0212394 | Length 45.0 mm | In distribution | |
| 55740009575 | 9.5 X 75 mm | In distribution | |
| 7643440 | In distribution | ||
| X0612690 | Outer Diameter 8.5 mm | In distribution | |
| 55840018085 | Length 85.0 mm | In distribution | |
| 75753059 | In distribution | ||
| 54840007545 | Length 45.0 mm | In distribution | |
| X0704025 | 6.35mm x 60mm / 4.5mm x 80mm 4.5mm CANNULATION | In distribution | |
| 1606006030 | Length 30.0 mm | In distribution | |
| X06123799 | Length 90.0 mm | In distribution | |
| 8114534 | Length 34.0 mm | In distribution | |
| 55410007550 | Length 50.0 mm | In distribution | |
| 7226540 | Length 40.0 mm | In distribution | |
| 55410006060 | Outer Diameter 6.0 mm | In distribution | |
| 5763170 | Width 6.0 mm | In distribution | |
| X0612560 | Length 100.0 mm | In distribution | |
| 7020760 | Length 60.0 mm | In distribution | |
| 7894530 | Length 30.0 mm | In distribution | |
| X0812238 | Length 65.0 mm | In distribution | |
| X0612692 | Outer Diameter 9.0 mm | In distribution | |
| 55811009045 | Length 45.0 mm | In distribution | |
| 54840045545 | Length 45.0 mm | In distribution | |
| 55840004525 | Outer Diameter 4.5 mm | In distribution | |
| 7642645 | In distribution | ||
| 1556006200 | Length 200.0 mm | In distribution | |
| 5763140 | Width 6.0 mm | In distribution | |
| X0709125 | Outer Diameter 7.5 mm | In distribution | |
| X0612387 | Length 95.0 mm | In distribution | |
| X70257590 | In distribution | ||
| X0808079 | Length 20.0 mm | In distribution | |
| X06123353 | Length 65.0 mm | In distribution | |
| 55740006065 | 6.0 X 65 mm | In distribution | |
| X0612428 | Outer Diameter 6.0 mm | In distribution | |
| 6641140 | Outer Diameter 4.0 mm | In distribution | |
| 55890006555 | Outer Diameter 6.5 mm | In distribution | |
| 55840015055 | Outer Diameter 5.0 mm | In distribution | |
| 7195540 | Length 40.0 mm | In distribution | |
| 9010014611 | DIA=5.5mm x ML=12mm | In distribution | |
| 54840008590 | Outer Diameter 8.5 mm | In distribution | |
| 7040650 | Outer Diameter 6.5 mm | In distribution | |
| X0810620 | Length 4.5 mm | In distribution | |
| 54840018065 | Length 65.0 mm | In distribution | |
| X0212495 | 5.0mm x 25mm | In distribution | |
| X0909353 | Length 25.0 mm | In distribution | |
| 55740009085 | 9.0 X 85 mm | In distribution | |
| NAV2016 | 5.5-6.5MM | In distribution | |
| 54840017540 | Outer Diameter 7.5 mm | In distribution | |
| 45410005545 | In distribution | ||
| 55840004555 | Outer Diameter 4.5 mm | In distribution | |
| X0612323 | Length 60.0 mm | In distribution | |
| X0212307 | Length 15.0 mm | In distribution | |
| 5440130 | In distribution | ||
| 7195555 | Outer Diameter 5.5 mm | In distribution | |
| X0612568 | 4.0mm x 45mm | In distribution | |
| 25840011211 | In distribution | ||
| 55840018545 | Outer Diameter 8.5 mm | In distribution | |
| X0612586 | 5.0mm x 15mm | In distribution | |
| 7221640 | Length 40.0 mm | In distribution | |
| X0808109 | Outer Diameter 6.5 mm | In distribution | |
| 25530011012 | In distribution | ||
| 25840019511 | In distribution | ||
| 55890006530 | Length 30.0 mm | In distribution | |
| 55811005055 | Length 55.0 mm | In distribution | |
| 7198540 | Length 40.0 mm | In distribution | |
| 55740009090 | 9.0 X 90 mm | In distribution | |
| 9010014618 | DIA=6.0mm x ML=12mm | In distribution | |
| 55811005570 | Outer Diameter 5.5 mm | In distribution | |
| X0212676 | Length 55.0 mm | In distribution | |
| 75407545 | Length 45.0 mm | In distribution | |
| 7642450 | In distribution | ||
| X0909340 | Length 25.0 mm | In distribution | |
| 55740006030 | 6.0 X 30 mm | In distribution | |
| 25530018511 | In distribution | ||
| X0808126 | Outer Diameter 8.5 mm | In distribution | |
| 55740006575 | 6.5 X 75 mm | In distribution | |
| 55890007511 | Length 110.0 mm | In distribution | |
| X06123399 | Length 70.0 mm | In distribution | |
| 6541023 | In distribution | ||
| X0609494 | Length 20.0 mm | In distribution | |
| X0612472 | Length 80.0 mm | In distribution | |
| 5542333 | 33mm x 36mm | In distribution | |
| 7641224 | In distribution | ||
| 75465525 | Outer Diameter 5.5 mm | In distribution | |
| 7225530 | Outer Diameter 5.5 mm | In distribution | |
| 55890008070 | Length 70.0 mm | In distribution | |
| X0612615 | 6.0mm x 50mm | In distribution | |
| 55840001050 | Length 50.0 mm | In distribution | |
| X0312268 | Length 35.0 mm | In distribution | |
| 6641155 | Outer Diameter 5.5 mm | In distribution | |
| X0212301 | Length 65.0 mm | In distribution | |
| 55811009065 | Length 65.0 mm | In distribution | |
| 1605006110 | Length 110.0 mm | In distribution | |
| 651001380 | Outer Diameter 5.5 mm | In distribution | |
| 55811015515 | Length 15.0 mm | In distribution | |
| 7571140 | Outer Diameter 5.5 mm | In distribution | |
| 54840045525 | Length 25.0 mm | In distribution | |
| 55840005075 | Length 75.0 mm | In distribution | |
| X1209830 | In distribution | ||
| 651101460 | Length 460.0 mm | In distribution | |
| X06123774 | Length 60.0 mm | In distribution | |
| 74445050 | Outer Diameter 5.0 mm | In distribution | |
| 7573445 | Outer Diameter 4.5 mm | In distribution | |
| 7021360 | Length 60.0 mm | In distribution | |
| 54840019045 | Outer Diameter 9.0 mm | In distribution | |
| 652001190 | Length 190.0 mm | In distribution | |
| 54740108095 | Length 95.0 mm | In distribution | |
| 99916545 | Length 45.0 mm | In distribution | |
| 54410005025 | Length 25.0 mm | In distribution | |
| 7571210 | Outer Diameter 5.5 mm | In distribution | |
| 55811005050 | Length 50.0 mm | In distribution | |
| X0812209 | Length 90.0 mm | In distribution | |
| X06123246 | Length 90.0 mm | In distribution | |
| 7042890 | Outer Diameter 8.5 mm | In distribution | |
| X0212494 | Length 20.0 mm | In distribution | |
| X0812057 | Length 35.0 mm | In distribution | |
| X0612292 | Length 15.0 mm | In distribution | |
| X0612527 | Length 85.0 mm | In distribution | |
| X0909349 | Length 30.0 mm | In distribution | |
| 55811015570 | Length 70.0 mm | In distribution | |
| 651001170 | Outer Diameter 5.5 mm | In distribution | |
| 55811015550 | Outer Diameter 5.5 mm | In distribution | |
| GX0617049 | In distribution | ||
| 8672115 | Length 115.0 mm | In distribution | |
| 5445122 | In distribution | ||
| 7191545 | Length 45.0 mm | In distribution | |
| X0812253 | Length 70.0 mm | In distribution | |
| 5541343 | Medium | In distribution | |
| X0612726 | Length 100.0 mm | In distribution | |
| 9010014614 | DIA=5.5mm x ML=13.5mm | In distribution | |
| 54840018565 | Outer Diameter 8.5 mm | In distribution | |
| 54840019085 | Outer Diameter 9.0 mm | In distribution | |
| 1606006190 | Length 190.0 mm | In distribution | |
| 55740007020 | 7.0 X 20 mm | In distribution | |
| 75465050 | Outer Diameter 5.0 mm | In distribution | |
| X0612592 | 5.0mm x 45mm | In distribution | |
| 55890007580 | Length 80.0 mm | In distribution | |
| 5541114 | Large | In distribution | |
| 5541191 | Medium | In distribution | |
| 55840008045 | Outer Diameter 8.0 mm | In distribution | |
| 86992450 | Length 50.0 mm | In distribution | |
| 55811015540 | Length 40.0 mm | In distribution | |
| X06123192 | Length 50.0 mm | In distribution | |
| X0612722 | Outer Diameter 9.5 mm | In distribution | |
| 1554006130 | Length 130.0 mm | In distribution | |
| X0612597 | 5.0mm x 70mm | In distribution | |
| X0612376 | Length 95.0 mm | In distribution | |
| 7895530 | Length 30.0 mm | In distribution | |
| X0411414 | Length 60.0 mm | In distribution | |
| X0212467 | Length 25.0 mm | In distribution | |
| X06123234 | Length 30.0 mm | In distribution | |
| 75406540 | Outer Diameter 6.5 mm | In distribution | |
| 75753019 | In distribution | ||
| 70468550 | In distribution | ||
| 55811017045 | Outer Diameter 7.0 mm | In distribution | |
| X0612593 | 5.0mm x 50mm | In distribution | |
| 55811009040 | Length 40.0 mm | In distribution | |
| 7020580 | Length 80.0 mm | In distribution | |
| 7040700 | Length 100.0 mm | In distribution | |
| X0612413 | Length 60.0 mm | In distribution | |
| X0312386 | 8.5mm x 70mm | In distribution | |
| 1476006420 | Length 420.0 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170679 | 2017-05-11 |
| K140449 | 2014-03-25 |
| K123246 | 2012-11-16 |
| K122433 | 2012-09-28 |
| K121764 | 2012-08-21 |
| K113529 | 2012-02-09 |
| K112473 | 2011-10-21 |
| K111510 | 2011-09-15 |
| K111457 | 2011-09-15 |
| K110676 | 2011-05-23 |
| K103049 | 2010-12-23 |
| K102807 | 2010-11-17 |
| K101772 | 2010-09-30 |
| K091445 | 2010-09-27 |
| K091797 | 2010-04-30 |
| K093434 | 2009-12-02 |
| K093058 | 2009-10-26 |
| K092676 | 2009-10-02 |
| K090740 | 2009-08-14 |
| K091442 | 2009-07-15 |
| K090390 | 2009-05-15 |
| K081080 | 2008-11-21 |
| K082236 | 2008-10-10 |
| K062254 | 2008-06-16 |
| K072429 | 2007-09-28 |
| K063670 | 2007-06-28 |
| K063417 | 2007-01-18 |
| K063083 | 2006-11-06 |
| K062807 | 2006-11-06 |
| K060615 | 2006-10-25 |
| K061592 | 2006-07-03 |
| K060203 | 2006-02-13 |
| K053474 | 2006-01-06 |
| K053101 | 2006-01-05 |
| K052747 | 2005-10-28 |
| K052609 | 2005-10-21 |
| K052144 | 2005-08-31 |
| K052187 | 2005-08-22 |
| K052054 | 2005-08-16 |
| K050439 | 2005-03-24 |
| K043488 | 2005-03-21 |
| K050282 | 2005-02-18 |
| K043321 | 2005-02-03 |
| K042962 | 2004-12-14 |
| K042886 | 2004-11-18 |
| K042790 | 2004-11-04 |
| K042167 | 2004-09-08 |
| K032560 | 2004-03-09 |
| K032033 | 2003-09-12 |
| K030285 | 2003-02-25 |
Recalls Naming This Product
3 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 | 2011-06-28 | Not classified | Other | Screws are longer then size etched on the screw. | 29 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.