CD Horizon™ Astute™ Spinal System
Peek ROD 1608451060 6.0 X 6.9MM STR 60MM
4manufacturers in China registered for this device type
9catalogue 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) | K191066 |
| Record published | 2020-08-14 |
| Record revised | 2024-07-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 60 to 125 mm; width 6.9 mm; length 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1608451060 | Outer Diameter 60.0 mm | In distribution |
| 1608451090 | Width 6.9 mm | In distribution |
| 1608451125 | Outer Diameter 125.0 mm | In distribution |
| 1608451035 | In distribution | |
| 1608451085 | Length 6.0 mm | In distribution |
| 1608451070 | In distribution | |
| 1608451110 | Length 6.0 mm | In distribution |
| 1608451065 | Outer Diameter 65.0 mm | In distribution |
| 1608451095 | Outer Diameter 95.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 311 |
| 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 |
| 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 |
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.