CD Horizon® Spinal System
SCR X06123714 5.5-6.0 STH RED MAS 6.5X45
7manufacturers in China registered for this device type
876catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K113174 |
| Record published | 2015-07-27 |
| Record revised | 2022-09-16 (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 4 to 700 mm; outer diameter 4 to 10.5 mm; width 4.75 to 6 mm; height 4.75 to 6.35 mm; circumference 5.5 to 6 mm; length 20.981 in; height 4.662 in; width 10.092 in |
| Distribution end date | 2026-04-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 55840017525 | Outer Diameter 7.5 mm | In distribution |
| 54740109570 | Length 70.0 mm | In distribution |
| 1555501065 | Length 65.0 mm | In distribution |
| 1556006040 | Length 40.0 mm | In distribution |
| 55811006050 | Outer Diameter 6.0 mm | In distribution |
| 661001220 | Outer Diameter 6.0 mm | In distribution |
| 55840001075 | Length 75.0 mm | In distribution |
| X06123714 | Length 45.0 mm | In distribution |
| 1605006500 | Length 500.0 mm | In distribution |
| 54740106545 | Length 45.0 mm | In distribution |
| X0812201 | Length 50.0 mm | In distribution |
| 5540130 | In distribution | |
| X06123280 | Length 70.0 mm | In distribution |
| X06123811 | Length 65.0 mm | In distribution |
| X0212674 | Length 45.0 mm | In distribution |
| 55740106535 | In distribution | |
| 5454135 | Height 4.75 mm | In distribution |
| 55840005535 | Length 35.0 mm | In distribution |
| 55410004075 | Outer Diameter 4.0 mm | In distribution |
| 55840001000 | Outer Diameter 10.0 mm | In distribution |
| X06123683 | Length 65.0 mm | In distribution |
| 55410005050 | Length 50.0 mm | In distribution |
| 55811018020 | Length 20.0 mm | In distribution |
| 55890004550 | Length 50.0 mm | In distribution |
| X0312263 | Length 90.0 mm | In distribution |
| 54740047540 | Length 40.0 mm | In distribution |
| X0812084 | Length 20.0 mm | In distribution |
| 55811017035 | Length 35.0 mm | In distribution |
| 5443230 | Length 30.0 mm | In distribution |
| X06123217 | Length 25.0 mm | In distribution |
| 661001460 | Length 460.0 mm | In distribution |
| X0812133 | Length 90.0 mm | In distribution |
| 55890009560 | Length 60.0 mm | In distribution |
| 1556006240 | Length 240.0 mm | In distribution |
| 7578302 | In distribution | |
| X06123637 | Length 55.0 mm | In distribution |
| 55840005550 | Outer Diameter 5.5 mm | In distribution |
| 9010005070 | Length 70.0 mm | In distribution |
| X0312281 | Length 20.0 mm | In distribution |
| 5564170 | Circumference 6.0 mm | In distribution |
| 54740105550 | Length 50.0 mm | In distribution |
| NAV0200 | In distribution | |
| 55811007060 | Length 60.0 mm | In distribution |
| 55410004545 | Outer Diameter 4.5 mm | In distribution |
| X0312421 | 9.5mm x 75mm | In distribution |
| 55840009020 | Length 20.0 mm | In distribution |
| X0612384 | Length 80.0 mm | In distribution |
| 54740105550 | In distribution | |
| 55410005525 | Length 25.0 mm | In distribution |
| X0612686 | Length 80.0 mm | In distribution |
| 55410006030 | Outer Diameter 6.0 mm | In distribution |
| 55890007560 | Length 60.0 mm | In distribution |
| 55811015065 | Length 65.0 mm | In distribution |
| 55410007560 | Outer Diameter 7.5 mm | In distribution |
| 55811019055 | Length 55.0 mm | In distribution |
| 1606006130 | Length 130.0 mm | In distribution |
| X06123793 | Length 60.0 mm | In distribution |
| 54740109580 | Outer Diameter 9.5 mm | In distribution |
| X0612720 | Outer Diameter 9.5 mm | In distribution |
| X06123187 | Length 25.0 mm | In distribution |
| X0612578 | 4.5mm x 45mm | In distribution |
| 25530017510 | In distribution | |
| 8672100 | Length 100.0 mm | In distribution |
| 54740107060 | Length 60.0 mm | In distribution |
| X06123831 | Length 80.0 mm | In distribution |
| X0612573 | 4.0mm x 70mm | In distribution |
| 55840007565 | Length 65.0 mm | In distribution |
| 55410005090 | Length 90.0 mm | In distribution |
| 1553201085 | In distribution | |
| X0212303 | Length 75.0 mm | In distribution |
| 55840008025 | Outer Diameter 8.5 mm | In distribution |
| X0812264 | Length 55.0 mm | In distribution |
| X0312402 | 9.0mm x 65mm | In distribution |
| 5540430 | In distribution | |
| 8672105 | In distribution | |
| 25740011050 | In distribution | |
| 55840006560 | Length 60.0 mm | In distribution |
| 1605006140 | Length 140.0 mm | In distribution |
| 652001100 | Outer Diameter 5.5 mm | In distribution |
| 55890009070 | Length 70.0 mm | In distribution |
| X0612569 | 4.0mm x 50mm | In distribution |
| X06123200 | Length 20.0 mm | In distribution |
| X0312394 | 9.0mm x 25mm | In distribution |
| 55410008015 | Outer Diameter 8.0 mm | In distribution |
| X06123312 | Length 40.0 mm | In distribution |
| 25740011090 | In distribution | |
| 25840011010 | In distribution | |
| X0212471 | Length 45.0 mm | In distribution |
| X06123382 | Length 55.0 mm | In distribution |
| 55890009511 | Outer Diameter 9.5 mm | In distribution |
| 1475006170 | Length 170.0 mm | In distribution |
| 55811008070 | Length 70.0 mm | In distribution |
| 8672075 | Length 75.0 mm | In distribution |
| 1556006360 | Length 360.0 mm | In distribution |
| X0612643 | 7.5mm x 20mm | In distribution |
| X0612308 | Length 80.0 mm | In distribution |
| X0312411 | 9.5mm x 25mm | In distribution |
| X0312272 | Length 55.0 mm | In distribution |
| 55840015045 | Outer Diameter 5.0 mm | In distribution |
| 55890007055 | Outer Diameter 7.0 mm | In distribution |
| 1555006370 | Length 370.0 mm | In distribution |
| 25740011180 | In distribution | |
| 25740018580 | In distribution | |
| X0612369 | Length 90.0 mm | In distribution |
| X0313389 | 4.5mm Side / 5.5mm Closed | In distribution |
| 6641165 | Outer Diameter 6.5 mm | In distribution |
| 8672065 | Length 65.0 mm | In distribution |
| X06123271 | Length 25.0 mm | In distribution |
| X06123750 | Length 35.0 mm | In distribution |
| 54740106540 | Outer Diameter 6.5 mm | In distribution |
| 55410005580 | Length 80.0 mm | In distribution |
| X0312437 | 10.0mm x 85mm | In distribution |
| X0212338 | Length 95.0 mm | In distribution |
| X06123349 | Length 45.0 mm | In distribution |
| 1606200700 | Length 700.0 mm | In distribution |
| 55840017020 | Outer Diameter 7.0 mm | In distribution |
| X06123396 | Length 55.0 mm | In distribution |
| 25130500 | In distribution | |
| 6641060 | Outer Diameter 6.0 mm | In distribution |
| 55811008035 | Length 35.0 mm | In distribution |
| 54740044530 | Outer Diameter 4.5 mm | In distribution |
| X0812236 | Length 55.0 mm | In distribution |
| 55840004545 | Outer Diameter 4.5 mm | In distribution |
| 5541322 | Small | In distribution |
| 55890009080 | Outer Diameter 9.0 mm | In distribution |
| 652101090 | Outer Diameter 5.5 mm | In distribution |
| 55840001565 | Outer Diameter 10.5 mm | In distribution |
| X06123833 | Length 90.0 mm | In distribution |
| X0812087 | Length 35.0 mm | In distribution |
| 55840005555 | Outer Diameter 5.5 mm | In distribution |
| 55890005035 | Length 35.0 mm | In distribution |
| 2950005 | In distribution | |
| 1476006400 | Length 400.0 mm | In distribution |
| 55840007511 | Length 110.0 mm | In distribution |
| 54890004530 | Length 30.0 mm | In distribution |
| X06123860 | Length 85.0 mm | In distribution |
| X0612710 | Length 20.0 mm | In distribution |
| X06123369 | Length 60.0 mm | In distribution |
| 25530018512 | In distribution | |
| 1555501115 | Length 115.0 mm | In distribution |
| X0212300 | Length 15.0 mm | In distribution |
| 55410006075 | Length 75.0 mm | In distribution |
| 55840009055 | Length 55.0 mm | In distribution |
| 651001210 | Outer Diameter 5.5 mm | In distribution |
| X0212677 | Length 60.0 mm | In distribution |
| 55840008525 | Length 25.0 mm | In distribution |
| X0312254 | Length 45.0 mm | In distribution |
| 55890009530 | Length 30.0 mm | In distribution |
| 25840017580 | In distribution | |
| X06123251 | Length 20.0 mm | In distribution |
| X0212574 | Length 70.0 mm | In distribution |
| 55840009590 | Outer Diameter 9.5 mm | In distribution |
| 55410006070 | Length 70.0 mm | In distribution |
| 55890004570 | Outer Diameter 4.5 mm | In distribution |
| X0212615 | Length 85.0 mm | In distribution |
| X0812245 | Length 100.0 mm | In distribution |
| 9010000825 | Length 50.0 mm | In distribution |
| 1475005080 | Length 80.0 mm | In distribution |
| 7069098 | n/a | In distribution |
| X0612574 | 4.0mm x 75mm | In distribution |
| 1475005085 | Length 85.0 mm | In distribution |
| X06123655 | Length 75.0 mm | In distribution |
| 55840016580 | Outer Diameter 6.5 mm | In distribution |
| 54740106565 | Length 65.0 mm | In distribution |
| 1555501040 | Length 40.0 mm | In distribution |
| X06123835 | Length 100.0 mm | In distribution |
| 54840045555 | Length 55.0 mm | In distribution |
| 25530011170 | In distribution | |
| 55890009000 | Length 100.0 mm | In distribution |
| X0812247 | Length 40.0 mm | In distribution |
| 1553201035 | In distribution | |
| X06123834 | Length 95.0 mm | In distribution |
| 55840018575 | Length 75.0 mm | In distribution |
| 25630011110 | In distribution | |
| 25840018570 | In distribution | |
| X0612699 | Outer Diameter 9.0 mm | In distribution |
| 1555006100 | Length 100.0 mm | In distribution |
| 1606006120 | Length 120.0 mm | In distribution |
| 55890008085 | Length 85.0 mm | In distribution |
| X06123632 | Length 30.0 mm | In distribution |
| 55410005550 | Outer Diameter 5.5 mm | In distribution |
| X0612631 | 7.0mm x 25mm | In distribution |
| 54740109560 | Outer Diameter 9.5 mm | In distribution |
| 55811006075 | Outer Diameter 6.0 mm | In distribution |
| 55840016025 | Outer Diameter 6.0 mm | In distribution |
| 55840016030 | Length 30.0 mm | In distribution |
| 1553201065 | In distribution | |
| X0312358 | 8.0mm x 25mm | In distribution |
| 1476006180 | Length 180.0 mm | In distribution |
| 54840044525 | Length 25.0 mm | In distribution |
| 55811018535 | Length 35.0 mm | In distribution |
| 1556006190 | Length 190.0 mm | In distribution |
| 8672040 | In distribution | |
| 55890008050 | Length 50.0 mm | In distribution |
| 55840009515 | Outer Diameter 9.5 mm | In distribution |
| X0212398 | Length 65.0 mm | In distribution |
| X0212402 | Length 85.0 mm | In distribution |
| X06123797 | Length 80.0 mm | In distribution |
| X06123663 | Length 45.0 mm | In distribution |
| 55840005530 | Outer Diameter 5.5 mm | In distribution |
| X0312292 | Length 75.0 mm | In distribution |
| 55811018090 | Length 90.0 mm | In distribution |
| 54740107540 | Outer Diameter 7.5 mm | In distribution |
| X0612677 | Outer Diameter 8.5 mm | In distribution |
| 55840007555 | Length 55.0 mm | In distribution |
| 25630011070 | In distribution | |
| 55890009515 | Length 15.0 mm | In distribution |
| X06123195 | Length 65.0 mm | In distribution |
| 5440030 | In distribution | |
| X0312307 | Length 55.0 mm | In distribution |
| 661101030 | Length 30.0 mm | In distribution |
| 55410007530 | Outer Diameter 7.5 mm | In distribution |
| 652001460 | Length 460.0 mm | In distribution |
| 55811019535 | Outer Diameter 9.5 mm | In distribution |
| X06123185 | Length 15.0 mm | In distribution |
| X06123792 | Length 55.0 mm | In distribution |
| X0812263 | Length 50.0 mm | In distribution |
| 662101110 | Length 110.0 mm | In distribution |
| 55840007550 | Outer Diameter 7.5 mm | In distribution |
| 5563260 | Length 60.0 mm | In distribution |
| 54740108580 | Outer Diameter 8.5 mm | In distribution |
| 55410004040 | Length 40.0 mm | In distribution |
| 55840009030 | Length 30.0 mm | In distribution |
| 55840006511 | Length 110.0 mm | In distribution |
| 1553200500 | In distribution | |
| 8672040 | Length 40.0 mm | In distribution |
| X0612325 | Length 70.0 mm | In distribution |
| 55811008090 | Outer Diameter 8.0 mm | In distribution |
| 6641170 | Outer Diameter 7.0 mm | In distribution |
| 9010005040 | Length 40.0 mm | In distribution |
| X06123203 | Length 35.0 mm | In distribution |
| 54740107045 | Length 45.0 mm | In distribution |
| 25630018550 | In distribution | |
| 55840006530 | Outer Diameter 6.5 mm | In distribution |
| 1605006060 | Length 60.0 mm | In distribution |
| 5540030 | Length 6.0 mm | In distribution |
| X0812218 | Length 50.0 mm | In distribution |
| 55811009585 | Outer Diameter 9.5 mm | In distribution |
| 55811018070 | Outer Diameter 8.0 mm | In distribution |
| X0812063 | Length 65.0 mm | In distribution |
| 55811006055 | Length 55.0 mm | In distribution |
| X06123229 | Length 85.0 mm | In distribution |
| X06123720 | Length 75.0 mm | In distribution |
| 1476006370 | Length 370.0 mm | In distribution |
| 55840004520 | Outer Diameter 4.5 mm | In distribution |
| 1554006050 | Length 50.0 mm | In distribution |
| X0812269 | Length 80.0 mm | In distribution |
| 55811004555 | Length 55.0 mm | In distribution |
| 55840001545 | Length 45.0 mm | In distribution |
| 55740107550 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| Olympic | Astura Medical | 951 |
| Nex-D2 | Next Orthosurgical | 887 |
| Arsenal | Alphatec Spine, Inc. | 820 |
| Apex-DL Spine System | Spinecraft LLC | 691 |
| Polaris™ 4.75 Spinal System | Biomet Spine | 413 |
| Expedium | Medos International Sàrl | 400 |
| Implanet Spine System | Implanet | 386 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
| Polaris 4.75 TI Spinal System | Biomet Spine | 256 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140276 | 2014-03-13 |
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.