Dynesys®
Dynesys® TL Cord Tensioner with Ratchet
4manufacturers in China registered for this device type
29catalogue numbers in this listing
7510(k) clearances naming this product code
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 | Zimmer Spine, Inc., United States |
|---|---|
| FDA product code | NQP |
| Device type | Posterior Metal/Polymer Spinal System, Fusion |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2016-06-23 |
| Record revised | 2025-01-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Angle 7 to 15 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07.01164.005 | In distribution | |
| 07.01164.002 | In distribution | |
| 07.01165.006 | In distribution | |
| 07.01295.001 | In distribution | |
| 07.01294.001 | Angle 15 ° | In distribution |
| 07.01165.010 | In distribution | |
| 07.01299.001 | Angle 15 ° | In distribution |
| 07.01284.001 | In distribution | |
| 07.01285.001 | In distribution | |
| 07.00766.701 | In distribution | |
| 07.01286.001 | In distribution | |
| 07.01293.001 | Angle 7 ° | In distribution |
| 07.01164.001 | In distribution | |
| 07.01165.009 | In distribution | |
| 07.01407.001 | In distribution | |
| 07.01292.001 | In distribution | |
| 07.01283.001 | In distribution | |
| 07.01165.007 | In distribution | |
| 07.01164.004 | In distribution | |
| 07.01279.001 | In distribution | |
| 07.01301.001 | In distribution | |
| 07.00737.701 | In distribution | |
| 07.01164.003 | In distribution | |
| 07.01296.001 | In distribution | |
| 07.01165.008 | In distribution | |
| 07.01290.001 | In distribution | |
| 07.01298.001 | In distribution | |
| 07.01297.001 | In distribution | |
| 07.01284.002 | 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 |
| 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 |
|---|---|
| K133164 | 2014-01-16 |
| K101704 | 2010-08-18 |
| K092234 | 2009-10-01 |
| K073347 | 2008-02-08 |
| K071879 | 2007-10-05 |
| K060638 | 2006-04-06 |
| K043565 | 2005-03-11 |
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.