CD Horizon® Spinal System
SCR X0612509 SOL 4.75 MAS Cann CC 8.5X85
4manufacturers in China registered for this device type
311catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | NQP |
| Device type | Posterior Metal/Polymer Spinal System, Fusion |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K061591 |
| Record published | 2015-07-16 |
| Record revised | 2024-09-11 (version 8) |
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 |
| Label carries | lot or batch number |
| Sizes | Length 3 to 500 mm; outer diameter 4 to 80 mm; height 7.2 mm; width 6.35 mm; length 3.5 to 12 cm |
| Distribution end date | 2026-01-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 75465020 | Outer Diameter 5.0 mm | In distribution |
| X0411413 | Length 30.0 mm | In distribution |
| 6543625 | Outer Diameter 6.5 mm | In distribution |
| 54840009535 | Length 35.0 mm | In distribution |
| 54840018075 | Length 75.0 mm | In distribution |
| X0612509 | Outer Diameter 8.5 mm | In distribution |
| 5442130 | Length 30-32MM | In distribution |
| 54840019070 | Length 70.0 mm | In distribution |
| 54840005545 | Length 45.0 mm | In distribution |
| 7571460 | Outer Diameter 5.5 mm | In distribution |
| 7220950 | In distribution | |
| X0612537 | Length 45.0 mm | In distribution |
| 54840004530 | Length 30.0 mm | In distribution |
| 54840018055 | Outer Diameter 8.0 mm | In distribution |
| X1216065 | In distribution | |
| 75464540 | Length 40.0 mm | In distribution |
| 7573545 | Length 45.0 mm | In distribution |
| 8104540 | Length 40.0 mm | In distribution |
| 54840018085 | Length 85.0 mm | In distribution |
| 99915540 | Length 40.0 mm | In distribution |
| X0612524 | Outer Diameter 9.0 mm | In distribution |
| 54840019580 | Length 80.0 mm | In distribution |
| 54840016030 | Outer Diameter 6.0 mm | In distribution |
| 54410006540 | Length 40.0 mm | In distribution |
| X0612552 | Outer Diameter 10.0 mm | In distribution |
| 7571300 | Outer Diameter 5.5 mm | In distribution |
| 99916540 | Length 40.0 mm | In distribution |
| 54840004520 | Outer Diameter 4.5 mm | In distribution |
| 54840011500 | Length 100.0 mm | In distribution |
| 54840006030 | Length 30.0 mm | In distribution |
| X0610020 | In distribution | |
| 54840008580 | Outer Diameter 8.5 mm | In distribution |
| 75465540 | Length 40.0 mm | In distribution |
| X0612422 | Length 55.0 mm | In distribution |
| 54840001585 | Length 85.0 mm | In distribution |
| 5442031 | Length 31.0 mm | In distribution |
| 7893095 | Length 95.0 mm | In distribution |
| 54840004525 | Length 25.0 mm | In distribution |
| 5441133 | Medium | In distribution |
| 7573430 | Outer Diameter 4.5 mm | In distribution |
| X1111561 | In distribution | |
| 54840014550 | Outer Diameter 4.5 mm | In distribution |
| 5441173 | Medium | In distribution |
| 54840019000 | Length 100.0 mm | In distribution |
| 54840008550 | Length 50.0 mm | In distribution |
| 7579070 | Length 70.0 mm | In distribution |
| 54840011095 | Outer Diameter 10.0 mm | In distribution |
| X0612498 | Length 30.0 mm | In distribution |
| X0610016 | In distribution | |
| 99461040 | 4cm | In distribution |
| X0612545 | Outer Diameter 9.5 mm | In distribution |
| 9240545 | Length 41.0 mm | In distribution |
| 54840008560 | Outer Diameter 8.5 mm | In distribution |
| 1475001040 | Length 40.0 mm | In distribution |
| X609707 | In distribution | |
| 75465520 | Length 20.0 mm | In distribution |
| 6541125 | In distribution | |
| 54840019570 | Outer Diameter 9.5 mm | In distribution |
| 54840009530 | Length 30.0 mm | In distribution |
| X0612536 | Outer Diameter 9.5 mm | In distribution |
| 54840008595 | Length 95.0 mm | In distribution |
| 8104519 | Length 19.0 mm | In distribution |
| 75753049 | In distribution | |
| 7660120 | In distribution | |
| X1216064 | In distribution | |
| X0612481 | Length 35.0 mm | In distribution |
| 7576302 | In distribution | |
| X0208041 | In distribution | |
| 1475001065 | Length 65.0 mm | In distribution |
| X0612420 | Length 25.0 mm | In distribution |
| 54840015515 | Length 15.0 mm | In distribution |
| 54840011000 | Length 100.0 mm | In distribution |
| 54840016080 | Length 80.0 mm | In distribution |
| 8114537 | Length 37.0 mm | In distribution |
| 54840005560 | Outer Diameter 5.5 mm | In distribution |
| X609708 | In distribution | |
| 54840018080 | Outer Diameter 8.0 mm | In distribution |
| 7571090 | Outer Diameter 5.5 mm | In distribution |
| 5441114 | Large | In distribution |
| 54840005535 | Length 35.0 mm | In distribution |
| X1111560 | In distribution | |
| X0610025 | In distribution | |
| 1475000500 | Length 500.0 mm | In distribution |
| 54840016515 | Outer Diameter 6.5 mm | In distribution |
| 54840018011 | Outer Diameter 8.0 mm | In distribution |
| 54410006025 | Length 25.0 mm | In distribution |
| X0612407 | Length 30.0 mm | In distribution |
| X0612398 | Length 55.0 mm | In distribution |
| 54840018030 | Outer Diameter 8.0 mm | In distribution |
| 54840016535 | Length 3.0 mm | In distribution |
| 54840018535 | Length 35.0 mm | In distribution |
| 54840005050 | Length 50.0 mm | In distribution |
| 5441142 | Small | In distribution |
| 54410005030 | Length 30.0 mm | In distribution |
| 54840001580 | Length 80.0 mm | In distribution |
| 5441104 | Large | In distribution |
| 54840016570 | Length 70.0 mm | In distribution |
| 7640120 | In distribution | |
| X0610247 | Length 45.0 mm | In distribution |
| 54840004060 | Outer Diameter 4.0 mm | In distribution |
| 99910100 | In distribution | |
| 6541021 | In distribution | |
| X0612558 | Length 90.0 mm | In distribution |
| 1475501030 | Length 30.0 mm | In distribution |
| X0612506 | Outer Diameter 8.5 mm | In distribution |
| 1475001110 | Length 110.0 mm | In distribution |
| X0612463 | Outer Diameter 7.0 mm | In distribution |
| 99915550 | Length 50.0 mm | In distribution |
| 5443110 | Length 10.0 mm | In distribution |
| 7573555 | Outer Diameter 5.5 mm | In distribution |
| 54840015060 | Length 60.0 mm | In distribution |
| X0612441 | Length 80.0 mm | In distribution |
| 54840019565 | Length 65.0 mm | In distribution |
| 1475501100 | Length 100.0 mm | In distribution |
| 54410005035 | Length 35.0 mm | In distribution |
| 8114525 | Length 25.0 mm | In distribution |
| 54840017040 | Length 40.0 mm | In distribution |
| 7573450 | Length 50.0 mm | In distribution |
| X0610027 | In distribution | |
| 7571030 | Outer Diameter 5.5 mm | In distribution |
| 7571440 | Outer Diameter 5.5 mm | In distribution |
| 75405545 | Length 45.0 mm | In distribution |
| X0612456 | Outer Diameter 7.0 mm | In distribution |
| 6543545 | Outer Diameter 5.5 mm | In distribution |
| 99461035 | 3.5cm | In distribution |
| X0612453 | Length 30.0 mm | In distribution |
| 54840011085 | Outer Diameter 10.0 mm | In distribution |
| 6541021 | In distribution | |
| 7570901 | In distribution | |
| 54840018020 | Outer Diameter 8.0 mm | In distribution |
| 75753059 | In distribution | |
| 6541215 | In distribution | |
| X0612528 | Length 90.0 mm | In distribution |
| 54840019030 | Length 30.0 mm | In distribution |
| 54840016575 | Outer Diameter 6.5 mm | In distribution |
| X0612447 | Length 65.0 mm | In distribution |
| 54840014530 | Length 30.0 mm | In distribution |
| X0612435 | Outer Diameter 6.0 mm | In distribution |
| 54840016055 | Outer Diameter 6.0 mm | In distribution |
| 75464555 | Outer Diameter 4.5 mm | In distribution |
| 54840016075 | Length 75.0 mm | In distribution |
| X0612504 | Outer Diameter 8.5 mm | In distribution |
| 54840016045 | Length 45.0 mm | In distribution |
| X0612455 | Length 40.0 mm | In distribution |
| 54840004565 | Outer Diameter 4.5 mm | In distribution |
| 6541119 | In distribution | |
| 54410005520 | Length 20.0 mm | In distribution |
| 54840019520 | Length 20.0 mm | In distribution |
| X0612555 | Outer Diameter 10.0 mm | In distribution |
| X0612466 | Length 50.0 mm | In distribution |
| 1475001045 | Length 45.0 mm | In distribution |
| X0612471 | Length 75.0 mm | In distribution |
| 5441101 | Small | In distribution |
| X0612553 | Length 95.0 mm | In distribution |
| X0610030 | In distribution | |
| 5441122 | Small | In distribution |
| 7573730 | Outer Diameter 7.5 mm | In distribution |
| 5441143 | Medium | In distribution |
| 54840016520 | Length 20.0 mm | In distribution |
| X0612557 | Outer Diameter 10.5 mm | In distribution |
| X0612479 | Length 25.0 mm | In distribution |
| X0612403 | Length 80.0 mm | In distribution |
| 54840015065 | Outer Diameter 5.0 mm | In distribution |
| 7571420 | Outer Diameter 5.5 mm | In distribution |
| X0612518 | Length 40.0 mm | In distribution |
| X0612444 | Length 25.0 mm | In distribution |
| 75464535 | Length 35.0 mm | In distribution |
| X0612449 | Length 75.0 mm | In distribution |
| X0612400 | Length 65.0 mm | In distribution |
| 54840018090 | Length 90.0 mm | In distribution |
| 75407540 | Length 40.0 mm | In distribution |
| X1007069 | Length 40.0 mm | In distribution |
| 54840018040 | Length 40.0 mm | In distribution |
| X609715 | In distribution | |
| 75407535 | Length 35.0 mm | In distribution |
| X0612442 | Outer Diameter 6.5 mm | In distribution |
| 54840015530 | Length 30.0 mm | In distribution |
| 54840018545 | Length 45.0 mm | In distribution |
| 7576301 | In distribution | |
| X0612507 | Outer Diameter 8.5 mm | In distribution |
| 54840005070 | Length 70.0 mm | In distribution |
| 6543530 | In distribution | |
| X609713 | In distribution | |
| 75464550 | Outer Diameter 4.5 mm | In distribution |
| X0612402 | Length 75.0 mm | In distribution |
| 1475001050 | Length 50.0 mm | In distribution |
| 7893130 | Outer Diameter 6.35 mm | In distribution |
| 54840017580 | Outer Diameter 7.5 mm | In distribution |
| 54840005520 | Outer Diameter 5.5 mm | In distribution |
| 99465140 | Withdrawn | |
| 7894130 | Length 130.0 mm | Withdrawn |
| 7895035 | Outer Diameter 5.5 mm | Withdrawn |
| 99445540 | Length 40.0 mm | Withdrawn |
| X99917565 | Withdrawn | |
| 54840009511 | Length 110.0 mm | Withdrawn |
| 75416060 | Outer Diameter 6.0 mm | Withdrawn |
| 54410009070 | Length 70.0 mm | Withdrawn |
| 54840008000 | Length 100.0 mm | Withdrawn |
| 99446530 | Length 30.0 mm | Withdrawn |
| 54840001095 | Outer Diameter 10.0 mm | Withdrawn |
| X99915555 | Withdrawn | |
| 75405550 | Outer Diameter 5.5 mm | Withdrawn |
| X99915545 | Withdrawn | |
| 54840009065 | Length 65.0 mm | Withdrawn |
| 54410005015 | Length 15.0 mm | Withdrawn |
| X0610022 | Withdrawn | |
| 99467085 | Length 8.5 cm | Withdrawn |
| 99435545 | Outer Diameter 5.5 mm | Withdrawn |
| 54410008055 | Length 55.0 mm | Withdrawn |
| 7895095 | Outer Diameter 5.5 mm | Withdrawn |
| X99918535 | Withdrawn | |
| 75415035 | Length 35.0 mm | Withdrawn |
| 54410009550 | Length 50.0 mm | Withdrawn |
| X99917070 | Withdrawn | |
| X0508137 | Length 55.0 mm | Withdrawn |
| 75417540 | Length 40.0 mm | Withdrawn |
| 54410008590 | Length 90.0 mm | Withdrawn |
| 54840009085 | Outer Diameter 9.0 mm | Withdrawn |
| 54840005515 | Outer Diameter 5.5 mm | Withdrawn |
| X0709251 | Height 7.2 mm | Withdrawn |
| X99917545 | Withdrawn | |
| 7571470 | Outer Diameter 5.5 mm | Withdrawn |
| 99467120 | Length 12.0 cm | Withdrawn |
| 54840008511 | Length 110.0 mm | Withdrawn |
| X99917030 | Withdrawn | |
| 75470560 | Withdrawn | |
| 54410004575 | Length 75.0 mm | Withdrawn |
| X0508131 | Length 25.0 mm | Withdrawn |
| 75470665 | Withdrawn | |
| 54410004560 | Length 60.0 mm | Withdrawn |
| 99462040 | 4cm | Withdrawn |
| X99917050 | Withdrawn | |
| 54410004015 | Length 15.0 mm | Withdrawn |
| 75466525 | Outer Diameter 6.5 mm | Withdrawn |
| X99916060 | Withdrawn | |
| 54840009090 | Length 90.0 mm | Withdrawn |
| X99915535 | Withdrawn | |
| X0709256 | Width 6.35 mm | Withdrawn |
| 7895065 | Outer Diameter 5.5 mm | Withdrawn |
| 75417530 | Outer Diameter 7.5 mm | Withdrawn |
| X0508122 | Length 35.0 mm | Withdrawn |
| 54840008045 | Length 45.0 mm | Withdrawn |
| 54410005580 | Length 80.0 mm | Withdrawn |
| 54840009011 | Outer Diameter 9.0 mm | Withdrawn |
| 54840009055 | Length 55.0 mm | Withdrawn |
| X99917045 | Withdrawn | |
| 54840007075 | Length 75.0 mm | Withdrawn |
| 54410007525 | Length 25.0 mm | Withdrawn |
| X0709252 | Height 7.2 mm | Withdrawn |
| 75415060 | Length 60.0 mm | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Transition | Globus Medical, Inc. | 278 |
| Dynesys® | Zimmer, Inc. | 139 |
| Dynesys® Top-Loading System | Zimmer, Inc. | 103 |
| Dynesys® | Zimmer Spine, Inc. | 29 |
| Zimmer® DTO® | Zimmer, Inc. | 15 |
| CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek, Inc. | 9 |
| Dynesys Dynamic Stabilization System | Highridge Medical, LLC | 5 |
| DSS Pedicle screw set, Ø5.0 x 30mm | Paradigm Spine GmbH | 2 |
| DSS Pedicle screw set, Ø5.0 x 40mm | Paradigm Spine GmbH | 2 |
| DSS Pedicle screw set, Ø7.0 x 45mm | Paradigm Spine GmbH | 2 |
| DSS Pedicle screw set, Ø5.0 x 50mm | Paradigm Spine GmbH | 2 |
| DSS Pedicle screw set, Ø8.0 x 50mm | Paradigm Spine GmbH | 2 |
Showing 12 of 83. All products under Posterior Metal/Polymer Spinal System, Fusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061304 | 2006-07-18 |
Recalls Naming This Product
2 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 | 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.