CD Horizon® Spinal System
SCR X02121194 5.5 Redmas TI Cann 10.5X35
13manufacturers in China registered for this device type
3,144catalogue numbers in this listing
17510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K122433 |
| Record published | 2015-10-19 |
| 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 to 700 mm; outer diameter 3.5 to 35 mm; height 4.75 to 40 mm; width 4.75 to 6.35 mm; circumference 5.5 to 6 mm; length 5 to 100 cm; length 1.55 to 20.998 in; angle 75 to 105 ° |
| Distribution end date | 2026-01-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 55811019525 | Length 25.0 mm | In distribution |
| X02121194 | Length 35.0 mm | In distribution |
| 8549013 | Rod Span 32MM | In distribution |
| 75445040 | Length 40.0 mm | In distribution |
| 7363530 | Length 30.0 mm | In distribution |
| X0208099 | Length 90.0 mm | In distribution |
| X1010509 | In distribution | |
| X0509157 | Length 36 to 39MM | In distribution |
| 1553201030 | In distribution | |
| 869-022 | In distribution | |
| 75445035 | Outer Diameter 5.0 mm | In distribution |
| 55840016560 | Length 60.0 mm | In distribution |
| 779145555 | 5.5MM Closed Diameter | In distribution |
| 54740109545 | Outer Diameter 9.5 mm | In distribution |
| 7542430 | Length 30.0 mm | In distribution |
| X0409383 | In distribution | |
| 7343315 | Outer Diameter 3.5 mm | In distribution |
| 6541213 | In distribution | |
| X0809496 | Outer Diameter 8.0 mm | In distribution |
| 55811004515 | Outer Diameter 4.5 mm | In distribution |
| 55840019540 | Length 40.0 mm | In distribution |
| X0809386 | Length 30.0 mm | In distribution |
| X1008244 | In distribution | |
| 55811018065 | Outer Diameter 8.0 mm | In distribution |
| X0411452 | Outer Diameter 9.5 mm | In distribution |
| X0312392 | 8.5mm x 100mm | In distribution |
| 7463630 | Length 30.0 mm | In distribution |
| 55840019515 | Length 15.0 mm | In distribution |
| 55890005045 | Length 45.0 mm | In distribution |
| X1209844 | In distribution | |
| 778116555 | In distribution | |
| X0210279 | Length 100.0 mm | In distribution |
| X0606032 | Length 65.0 mm | In distribution |
| X0210283 | Length 100.0 mm | In distribution |
| 1475501075 | Length 75.0 mm | In distribution |
| 55840018520 | Length 20.0 mm | In distribution |
| 75647555 | Outer Diameter 7.5 mm | In distribution |
| X1211040 | In distribution | |
| 7543425 | Length 25.0 mm | In distribution |
| 55840006040 | Outer Diameter 6.0 mm | In distribution |
| 70469580 | In distribution | |
| X06123713 | Length 40.0 mm | In distribution |
| X0809485 | Length 100.0 mm | In distribution |
| X0803019R | 19mm | In distribution |
| 8103533 | Length 33.0 mm | In distribution |
| X1008206 | In distribution | |
| X0909496 | Length 30.0 mm | In distribution |
| X0212635 | Length 90.0 mm | In distribution |
| 54410005555 | Length 55.0 mm | In distribution |
| X0809444 | Length 65.0 mm | In distribution |
| X0809363 | Length 85.0 mm | In distribution |
| 7893090 | Outer Diameter 6.35 mm | In distribution |
| 7042760 | Length 60.0 mm | In distribution |
| 1553201060 | In distribution | |
| X06123371 | Length 70.0 mm | In distribution |
| 55811005075 | Outer Diameter 5.0 mm | In distribution |
| 7021740 | Outer Diameter 7.5 mm | In distribution |
| 55410007511 | Length 110.0 mm | In distribution |
| 55811015555 | Outer Diameter 5.5 mm | In distribution |
| X0612584 | 4.5mm x 75mm | In distribution |
| X02121166 | Length 55.0 mm | In distribution |
| 55840005015 | Outer Diameter 5.0 mm | In distribution |
| 7040845 | Length 45.0 mm | In distribution |
| X1010445 | In distribution | |
| X0303550L | In distribution | |
| X0708362 | Outer Diameter 7.5 mm | In distribution |
| X1010802 | In distribution | |
| X1010687 | Length 65.0 mm | In distribution |
| X0808083 | Length 40.0 mm | In distribution |
| 1553201080 | In distribution | |
| X1010480 | In distribution | |
| X0212601 | Length 15.0 mm | In distribution |
| X1010809 | In distribution | |
| 661101075 | Length 75.0 mm | In distribution |
| X06123712 | Length 355.0 mm | In distribution |
| 55840005085 | Outer Diameter 5.0 mm | In distribution |
| X1010405 | In distribution | |
| X0303551L | In distribution | |
| 1556006060 | Length 60.0 mm | In distribution |
| 55410008520 | Length 20.0 mm | In distribution |
| X1009493 | Length 70.0 mm | In distribution |
| 154213555 | In distribution | |
| X0311314 | Length 80.0 mm | In distribution |
| X0411275 | Length 85.0 mm | In distribution |
| X0612712 | Outer Diameter 9.5 mm | In distribution |
| 76644530 | In distribution | |
| X0212324 | Length 25.0 mm | In distribution |
| X0612628 | 6.5mm x 75mm | In distribution |
| 5442019 | Length 19.0 mm | In distribution |
| X0710956 | In distribution | |
| X0410165 | Outer Diameter 5.5 mm | In distribution |
| 7542425 | Length 25.0 mm | In distribution |
| 8699100 | Length 100.0 mm | In distribution |
| X0612572 | 4.0mm x 65mm | In distribution |
| X0612713 | Length 35.0 mm | In distribution |
| X02121015 | Length 100.0 mm | In distribution |
| 55811007040 | Outer Diameter 7.0 mm | In distribution |
| X1010475 | In distribution | |
| X1010412 | In distribution | |
| 1556006480 | Length 480.0 mm | In distribution |
| X0312301 | Length 25.0 mm | In distribution |
| 55840018585 | Outer Diameter 8.5 mm | In distribution |
| 54840016020 | Outer Diameter 6.0 mm | In distribution |
| X0212660 | Length 45.0 mm | In distribution |
| 8690080 | Length 80.0 mm | In distribution |
| 2950002 | In distribution | |
| 75458550 | Outer Diameter 8.5 mm | In distribution |
| 55410006015 | Outer Diameter 6.0 mm | In distribution |
| X06123342 | Length 95.0 mm | In distribution |
| 54740108045 | Length 45.0 mm | In distribution |
| 7574141 | Width 10.115 in | In distribution |
| 859-540 | Length 40.0 mm | In distribution |
| X09103500 | In distribution | |
| 778244555 | In distribution | |
| 7578560 | Length 60.0 mm | In distribution |
| 7542660 | Length 60.0 mm | In distribution |
| X1010512 | In distribution | |
| 55890007525 | Length 25.0 mm | In distribution |
| X02121030 | Length 95.0 mm | In distribution |
| 6543655 | Outer Diameter 6.5 mm | In distribution |
| X0609667 | Length 35.0 mm | In distribution |
| X06123658 | Length 20.0 mm | In distribution |
| 55811005550 | Length 50.0 mm | In distribution |
| X0812124 | Length 45.0 mm | In distribution |
| 76648530 | Outer Diameter 8.5 mm | In distribution |
| 778146565 | In distribution | |
| 54840015080 | Outer Diameter 5.0 mm | In distribution |
| X0710999 | In distribution | |
| X09103532 | In distribution | |
| 859-530 | Length 30.0 mm | In distribution |
| X0110228 | In distribution | |
| X0710754 | Length 55.0 mm | In distribution |
| 84509H | In distribution | |
| 55840011595 | Length 95.0 mm | In distribution |
| 8110716 | Length 16.0 mm | In distribution |
| 54740045530 | Length 30.0 mm | In distribution |
| 7542645 | Length 45.0 mm | In distribution |
| 55811006540 | Outer Diameter 6.5 mm | In distribution |
| X0509156 | Length 34 to 36MM | In distribution |
| 74446030 | Length 30.0 mm | In distribution |
| X0909483 | Length 50.0 mm | In distribution |
| 1555006440 | Length 440.0 mm | In distribution |
| 7463540 | Length 40.0 mm | In distribution |
| X0311326 | Length 75.0 mm | In distribution |
| 7892850 | Outer Diameter 8.5 mm | In distribution |
| 55811007545 | Length 45.0 mm | In distribution |
| X0411229 | Outer Diameter 5.5 mm | In distribution |
| 76446525 | In distribution | |
| 75446050 | Outer Diameter 6.0 mm | In distribution |
| 7892545 | Length 45.0 mm | In distribution |
| X70255550 | In distribution | |
| 1475006270 | Length 270.0 mm | In distribution |
| 84107CET | In distribution | |
| X1209823 | In distribution | |
| X0911009 | Length 26.5 mm | In distribution |
| X0312258 | Length 65.0 mm | In distribution |
| X1010484 | In distribution | |
| 55840017085 | Outer Diameter 7.0 mm | In distribution |
| X0612330 | Length 95.0 mm | In distribution |
| 55890005070 | Outer Diameter 5.0 mm | In distribution |
| 55840006535 | Length 35.0 mm | In distribution |
| X0411234 | Length 70.0 mm | In distribution |
| X0911089 | Length 19.0 mm | In distribution |
| 7041310 | Length 10.0 mm | In distribution |
| X1010448 | In distribution | |
| X0208318 | Outer Diameter 5.5 mm | In distribution |
| 84505LH | In distribution | |
| 75646035 | Outer Diameter 6.0 mm | In distribution |
| X1010739 | Length 70.0 mm | In distribution |
| 7563440 | D-Diameter 4.5MM | In distribution |
| X0411432 | Outer Diameter 9.0 mm | In distribution |
| X0710885 | In distribution | |
| X02121159 | Length 100.0 mm | In distribution |
| 1554006240 | Length 240.0 mm | In distribution |
| X06123657 | Length 15.0 mm | In distribution |
| X0210255 | Length 90.0 mm | In distribution |
| X0312339 | 7.5mm x 25mm | In distribution |
| X0812210 | Length 95.0 mm | In distribution |
| X0711364 | Outer Diameter 7.5 mm | In distribution |
| X06123205 | Length 45.0 mm | In distribution |
| 9010005030 | Length 30.0 mm | In distribution |
| X0710850 | In distribution | |
| X0710935 | In distribution | |
| 5563240 | 5.5-6.0MM | In distribution |
| 662101160 | Length 160.0 mm | In distribution |
| X0411152 | Outer Diameter 32.0 mm | In distribution |
| X0710946 | In distribution | |
| 86944535 | Length 35.0 mm | In distribution |
| 7576555 | In distribution | |
| X70259511 | In distribution | |
| X0409379 | In distribution | |
| X0809375 | Length 60.0 mm | In distribution |
| X0210261 | Length 60.0 mm | In distribution |
| 75456050 | Outer Diameter 6.0 mm | In distribution |
| X0606037 | Length 60.0 mm | In distribution |
| 1606006100 | Length 100.0 mm | In distribution |
| X0711391 | Outer Diameter 10.5 mm | In distribution |
| 7562645 | D-Diameter 6MM | In distribution |
| X0710887 | In distribution | |
| X0612404 | Length 15.0 mm | In distribution |
| 55890004030 | Length 30.0 mm | In distribution |
| X0711370 | Outer Diameter 8.5 mm | In distribution |
| 55890007565 | Length 65.0 mm | In distribution |
| X0411273 | Outer Diameter 10.5 mm | In distribution |
| X06123826 | Length 55.0 mm | In distribution |
| 55811008550 | Outer Diameter 8.5 mm | In distribution |
| 8114555M | In distribution | |
| 55840016575 | Length 75.0 mm | In distribution |
| 662001055 | Length 55.0 mm | In distribution |
| X0612309 | Length 15.0 mm | In distribution |
| 7461113 | Medium | In distribution |
| X0909066 | 30 Degrees | In distribution |
| 74446540 | Length 40.0 mm | In distribution |
| X0812096 | Length 80.0 mm | In distribution |
| X0609533 | Length 95.0 mm | In distribution |
| 55840005590 | Length 90.0 mm | In distribution |
| 25840017590 | In distribution | |
| 7642655 | In distribution | |
| X0411448 | Length 100.0 mm | In distribution |
| X0710957 | Length 95.0 mm | In distribution |
| 7661163 | In distribution | |
| 75444020 | Outer Diameter 4.0 mm | In distribution |
| 55840008550 | Length 50.0 mm | In distribution |
| 8579018 | In distribution | |
| 55811019545 | Outer Diameter 9.5 mm | In distribution |
| 86992440 | Length 40.0 mm | In distribution |
| 55811009520 | Outer Diameter 9.5 mm | In distribution |
| 55840018550 | Outer Diameter 8.5 mm | In distribution |
| X0306432 | In distribution | |
| X09103493 | In distribution | |
| X0204059 | Length 60.0 mm | In distribution |
| X02121002 | Length 35.0 mm | In distribution |
| X09103497 | In distribution | |
| 7021840 | Length 40.0 mm | In distribution |
| 75457560 | Outer Diameter 7.5 mm | In distribution |
| X06123710 | Length 25.0 mm | In distribution |
| 7892755 | Outer Diameter 7.5 mm | In distribution |
| X0808091 | Length 45.0 mm | In distribution |
| 1555006220 | Length 220.0 mm | In distribution |
| X0710990 | In distribution | |
| X1010461 | In distribution | |
| X0212323 | Length 20.0 mm | In distribution |
| 75447525 | Outer Diameter 7.5 mm | In distribution |
| X0710684 | Length 45.0 mm | In distribution |
| 1555006050 | Length 50.0 mm | In distribution |
| X0312367 | 8.0mm x 70mm | In distribution |
| 70465530 | In distribution | |
| 99472395 | Large | In distribution |
| 7221550 | Length 50.0 mm | In distribution |
| X0212673 | Length 40.0 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
| Polaris 5.5 Spinal System | Biomet Spine | 707 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061915 | 2006-07-25 |
| K043343 | 2004-12-28 |
| K034056 | 2004-04-21 |
| K040072 | 2004-02-12 |
| K033322 | 2003-12-15 |
| K020247 | 2002-07-22 |
| K013962 | 2002-06-20 |
| K020699 | 2002-05-28 |
| K014076 | 2001-12-27 |
| K010720 | 2001-04-11 |
| K010249 | 2001-02-23 |
| K000641 | 2000-12-22 |
| K002399 | 2000-09-27 |
| K001255 | 2000-07-11 |
| K001066 | 2000-06-22 |
| K000453 | 2000-03-10 |
| K000476 | 2000-03-10 |
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.