CD Horizon® Spinal System
SCR X0710804 5.5 SAS TI Ogthn CAN 9.0X50
13manufacturers in China registered for this device type
2,342catalogue numbers in this listing
23510(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, Spinal Pedicle Fixation
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K981676 |
| Record published | 2015-06-26 |
| 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 6.35 to 700 mm; outer diameter 3.35 to 37 mm; height 4.75 to 34 mm; width 4.75 to 6.35 mm; circumference 5.5 to 6 mm; length 7 to 15 cm |
| Distribution end date | 2026-01-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X0807012 | Length 42.5 mm | In distribution |
| X0711356 | Outer Diameter 6.5 mm | In distribution |
| 74446045 | Outer Diameter 6.0 mm | In distribution |
| 86945540 | Length 40.0 mm | In distribution |
| 651001030 | Outer Diameter 5.5 mm | In distribution |
| X06123796 | Length 75.0 mm | In distribution |
| 54840019540 | Outer Diameter 9.5 mm | In distribution |
| 1556006410 | Length 410.0 mm | In distribution |
| 55840007520 | Length 20.0 mm | In distribution |
| X0312429 | 10.0mm x 45mm | In distribution |
| 54840007570 | Length 70.0 mm | In distribution |
| X1010792 | Length 80.0 mm | In distribution |
| 7197575 | Length 75.0 mm | In distribution |
| X0708358 | Length 65.0 mm | In distribution |
| 76698560 | Length 60.0 mm | In distribution |
| X0612333 | Length 25.0 mm | In distribution |
| 5442034 | Length 34.0 mm | In distribution |
| 848-645 | In distribution | |
| 75464060 | Outer Diameter 4.0 mm | In distribution |
| 75656560 | Outer Diameter 6.5 mm | In distribution |
| 55811015530 | Length 30.0 mm | In distribution |
| 55811005030 | Outer Diameter 5.0 mm | In distribution |
| 76448535 | In distribution | |
| X0612697 | Length 45.0 mm | In distribution |
| 6541217 | In distribution | |
| X0212505 | Length 75.0 mm | In distribution |
| 55410006000 | Outer Diameter 6.0 mm | In distribution |
| X0609485 | Length 20.0 mm | In distribution |
| X0909465 | Length 45.0 mm | In distribution |
| 76646035 | Length 35.0 mm | In distribution |
| 86747535 | Length 35.0 mm | In distribution |
| X0612371 | Length 100.0 mm | In distribution |
| 55840016090 | Outer Diameter 6.0 mm | In distribution |
| 86945555 | Length 55.0 mm | In distribution |
| 99472165 | Small | In distribution |
| 54840017035 | Outer Diameter 7.0 mm | In distribution |
| 55840009075 | Outer Diameter 9.0 mm | In distribution |
| 76445045 | In distribution | |
| X0911237 | Length 40.0 mm | In distribution |
| 7563435 | D-Diameter 4.5MM | In distribution |
| 7041840 | Outer Diameter 8.5 mm | In distribution |
| X0809488 | Length 30.0 mm | In distribution |
| X0212600 | Length 110.0 mm | In distribution |
| X1010613 | Outer Diameter 4.0 mm | In distribution |
| X0212678 | Length 65.0 mm | In distribution |
| 54890006535 | Outer Diameter 6.5 mm | In distribution |
| 9010000828 | Length 65.0 mm | In distribution |
| X0909533 | Length 45.0 mm | In distribution |
| 8110611 | Length 11.0 mm | In distribution |
| 7461122 | In distribution | |
| X0312366 | 8.0mm x 65mm | In distribution |
| X1010554 | In distribution | |
| 7363425 | Outer Diameter 4.5 mm | In distribution |
| 55811015015 | Length 15.0 mm | In distribution |
| X02121046 | Length 95.0 mm | In distribution |
| X0411456 | Length 55.0 mm | In distribution |
| X0411237 | Outer Diameter 6.0 mm | In distribution |
| 8104528M | In distribution | |
| X0708342 | Length 30.0 mm | In distribution |
| X0212389 | Length 75.0 mm | In distribution |
| 7195535 | Length 35.0 mm | In distribution |
| X0204058 | Length 15.0 mm | In distribution |
| 55811008540 | Length 40.0 mm | In distribution |
| X1208032 | In distribution | |
| 76644525 | In distribution | |
| 7892740 | Outer Diameter 7.5 mm | In distribution |
| X7042810 | Outer Diameter 8.0 mm | In distribution |
| 75446540 | Outer Diameter 6.5 mm | In distribution |
| 55840009570 | Outer Diameter 9.5 mm | In distribution |
| 86946550 | Length 50.0 mm | In distribution |
| 662001075 | Length 75.0 mm | In distribution |
| 7663525 | In distribution | |
| 8688499 | Length 19.0 mm | In distribution |
| 74644035 | Outer Diameter 4.0 mm | In distribution |
| X0809378 | Length 75.0 mm | In distribution |
| X0612339 | Length 55.0 mm | In distribution |
| X0312326 | 7.0mm x 55mm | In distribution |
| 75655560 | Outer Diameter 5.5 mm | In distribution |
| 661001190 | Outer Diameter 6.0 mm | In distribution |
| 75495535 | Outer Diameter 5.5 mm | In distribution |
| 7341112 | Medium | In distribution |
| X0612589 | 5.0mm x 30mm | In distribution |
| X0510299 | Length 65.0 mm | In distribution |
| 54740105545 | Outer Diameter 5.5 mm | In distribution |
| X0312335 | 7.0mm x 100mm | In distribution |
| X02121128 | Length 25.0 mm | In distribution |
| X0411228 | Outer Diameter 5.5 mm | In distribution |
| X0612414 | Length 65.0 mm | In distribution |
| 55840016570 | Length 70.0 mm | In distribution |
| X0612702 | Outer Diameter 9.0 mm | In distribution |
| X0710879 | In distribution | |
| X1010571 | In distribution | |
| 54740107020 | Length 20.0 mm | In distribution |
| X0809330 | Outer Diameter 8.5 mm | In distribution |
| X0312408 | 9.0mm x 95mm | In distribution |
| 653001500 | Outer Diameter 5.5 mm | In distribution |
| X1010492 | In distribution | |
| X1216067 | In distribution | |
| 7643445 | In distribution | |
| 55840005540 | Outer Diameter 5.5 mm | In distribution |
| 652001035 | Length 35.0 mm | In distribution |
| 7030550 | Length 50.0 mm | In distribution |
| X1010466 | In distribution | |
| 55890006045 | Length 45.0 mm | In distribution |
| 7541174 | Large | In distribution |
| 76496560 | In distribution | |
| X06123323 | Length 95.0 mm | In distribution |
| 75446555 | Outer Diameter 6.5 mm | In distribution |
| 75644545 | Outer Diameter 4.5 mm | In distribution |
| 76647540 | Outer Diameter 7.5 mm | In distribution |
| X0212409 | Length 110.0 mm | In distribution |
| 661001100 | Length 100.0 mm | In distribution |
| X1008180 | In distribution | |
| 8690065 | Length 65.0 mm | In distribution |
| 651001420 | Outer Diameter 5.5 mm | In distribution |
| X1010780 | Outer Diameter 9.0 mm | In distribution |
| 75496540 | Outer Diameter 6.5 mm | In distribution |
| X0612421 | Length 30.0 mm | In distribution |
| 6541123 | In distribution | |
| X1209862 | In distribution | |
| X06123815 | Length 85.0 mm | In distribution |
| X06123309 | Length 25.0 mm | In distribution |
| X0711007 | In distribution | |
| X0411439 | Length 55.0 mm | In distribution |
| 7898530 | Length 30.0 mm | In distribution |
| 651101300 | Outer Diameter 5.5 mm | In distribution |
| X0803019C | 19mm | In distribution |
| 7343525 | Outer Diameter 5.5 mm | In distribution |
| 8699085 | Length 85.0 mm | In distribution |
| X1010488 | In distribution | |
| 7575545 | In distribution | |
| 7541322 | Small | In distribution |
| X0612621 | 6.0mm x 80mm | In distribution |
| 7042430 | Outer Diameter 6.35 mm | In distribution |
| 1553201100 | In distribution | |
| 55840011065 | Length 65.0 mm | In distribution |
| X0811183 | Length 40.0 mm | In distribution |
| 8690035 | Length 35.0 mm | In distribution |
| 8699050 | Length 50.0 mm | In distribution |
| X06123760 | Length 85.0 mm | In distribution |
| 55890006055 | Length 55.0 mm | In distribution |
| X0612711 | Length 25.0 mm | In distribution |
| 75696530 | Outer Diameter 6.5 mm | In distribution |
| 76698530 | Outer Diameter 8.5 mm | In distribution |
| 8549301 | Outer Diameter 4.5 mm | In distribution |
| X0411224 | Length 95.0 mm | In distribution |
| 8110717 | In distribution | |
| X0711335 | Length 75.0 mm | In distribution |
| 55840017511 | Length 110.0 mm | In distribution |
| X0209267 | In distribution | |
| X06123661 | Length 35.0 mm | In distribution |
| 7663630 | In distribution | |
| 55840004080 | Outer Diameter 4.0 mm | In distribution |
| 25740011290 | In distribution | |
| X0411245 | Outer Diameter 7.5 mm | In distribution |
| 75455555 | Outer Diameter 5.5 mm | In distribution |
| X0911269 | Length 60.0 mm | In distribution |
| 75645530 | Outer Diameter 5.5 mm | In distribution |
| 8690095 | Length 95.0 mm | In distribution |
| X0808092 | Outer Diameter 5.5 mm | In distribution |
| X06123775 | Length 65.0 mm | In distribution |
| X1013213 | 5.5/6.0mm | In distribution |
| 7561198 | In distribution | |
| X0212639 | Length 25.0 mm | In distribution |
| X0612603 | 5.5mm x 60mm | In distribution |
| 54840016015 | Length 15.0 mm | In distribution |
| X0410155 | Length 40.0 mm | In distribution |
| X02121126 | Length 95.0 mm | In distribution |
| X0709119 | Length 40.0 mm | In distribution |
| 7642540 | In distribution | |
| 55840017025 | Length 25.0 mm | In distribution |
| X0812152 | Length 90.0 mm | In distribution |
| X0411477 | Length 75.0 mm | In distribution |
| 848-528 | In distribution | |
| X02121059 | Length 80.0 mm | In distribution |
| 651101160 | Outer Diameter 5.5 mm | In distribution |
| 54740045560 | Length 60.0 mm | In distribution |
| X0911098 | Length 32.5 mm | In distribution |
| 76448570 | In distribution | |
| 8549300 | Outer Diameter 4.5 mm | In distribution |
| 7641203 | In distribution | |
| 75497525 | Outer Diameter 7.5 mm | In distribution |
| X0809391 | Outer Diameter 5.0 mm | In distribution |
| X0312242 | Length 55.0 mm | In distribution |
| 75446520 | Outer Diameter 6.5 mm | In distribution |
| 7020690 | Outer Diameter 6.5 mm | In distribution |
| 55811014565 | Length 65.0 mm | In distribution |
| X0311316 | Length 90.0 mm | In distribution |
| X0212509 | Length 15.0 mm | In distribution |
| 7563535 | DIA-Diameter 5.5MM | In distribution |
| 5441342 | Small | In distribution |
| X06123848 | Length 95.0 mm | In distribution |
| X0602551R | In distribution | |
| X0212591 | Length 60.0 mm | In distribution |
| X0809239 | Outer Diameter 8.5 mm | In distribution |
| X0711369 | Outer Diameter 8.5 mm | In distribution |
| 7543535 | D-Diameter 5.5MM | In distribution |
| 7022745 | Length 45.0 mm | In distribution |
| 5763150 | Length 50.0 mm | In distribution |
| X06123676 | Length 30.0 mm | In distribution |
| 848-640 | In distribution | |
| 55811016075 | Length 75.0 mm | In distribution |
| X0609499 | Length 45.0 mm | In distribution |
| X0311124 | In distribution | |
| X1010775 | Outer Diameter 8.5 mm | In distribution |
| 75657525 | Outer Diameter 7.5 mm | In distribution |
| 7573740 | Outer Diameter 7.5 mm | In distribution |
| X0811187 | Length 70.0 mm | In distribution |
| 779146555 | 5.5MM Closed Diameter | In distribution |
| 9010000640 | Length 45.0 mm | In distribution |
| 75654535 | Outer Diameter 4.5 mm | In distribution |
| X70255530 | In distribution | |
| 7461162 | In distribution | |
| 55840019511 | Outer Diameter 9.5 mm | In distribution |
| 1476006490 | Length 490.0 mm | In distribution |
| 54840006570 | Outer Diameter 6.5 mm | In distribution |
| X0809465 | Length 85.0 mm | In distribution |
| X0612354 | Length 110.0 mm | In distribution |
| X0809361 | Length 75.0 mm | In distribution |
| 651001060 | Outer Diameter 5.5 mm | In distribution |
| X06123754 | Length 55.0 mm | In distribution |
| 7643660 | In distribution | |
| 7342420 | Outer Diameter 4.0 mm | In distribution |
| X0110218 | In distribution | |
| 7579085 | Outer Diameter 6.35 mm | In distribution |
| 76445540 | In distribution | |
| 7893100 | Outer Diameter 6.35 mm | In distribution |
| X0710752 | Length 45.0 mm | In distribution |
| 76444520 | In distribution | |
| X0404551R | Medium | In distribution |
| 8672065 | Length 65.0 mm | In distribution |
| X1010667 | Length 50.0 mm | In distribution |
| 1476006150 | Length 150.0 mm | In distribution |
| 76646045 | Outer Diameter 6.0 mm | In distribution |
| X0911123 | Length 45.0 mm | In distribution |
| 7541163 | Medium | In distribution |
| 7363315 | Outer Diameter 3.5 mm | In distribution |
| X0311104 | In distribution | |
| 55811004060 | Outer Diameter 4.0 mm | In distribution |
| X0210273 | Length 70.0 mm | In distribution |
| X02121077 | Length 90.0 mm | In distribution |
| 7191725 | Length 25.0 mm | In distribution |
| X0212671 | Length 100.0 mm | In distribution |
| X1208030 | In distribution | |
| 86745550 | Length 50.0 mm | In distribution |
| 7576530 | In distribution | |
| 75448555 | Outer Diameter 8.5 mm | In distribution |
| 55811009015 | Length 15.0 mm | In distribution |
| X06123282 | Length 80.0 mm | In distribution |
| 99653502 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
| Astra Spine System | Spinecraft LLC | 786 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062879 | 2006-12-22 |
| K062606 | 2006-09-25 |
| K053483 | 2006-01-05 |
| K042210 | 2004-11-04 |
| K042453 | 2004-10-07 |
| K041777 | 2004-09-03 |
| K041030 | 2004-06-30 |
| K041118 | 2004-05-28 |
| K040583 | 2004-03-31 |
| K033495 | 2003-12-03 |
| K033271 | 2003-11-06 |
| K031967 | 2003-09-17 |
| K032578 | 2003-09-17 |
| K032037 | 2003-09-04 |
| K031833 | 2003-09-03 |
| K031888 | 2003-06-27 |
| K030932 | 2003-05-16 |
| K030840 | 2003-05-15 |
| K022778 | 2002-09-18 |
| K021106 | 2002-05-03 |
| K011029 | 2001-06-05 |
| K011067 | 2001-05-04 |
| K000991 | 2000-04-18 |
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.