FDA.reportPublic FDA data

Dynesys Dynamic Stabilization System

Primary DI
03662663109864
Brand
Dynesys Dynamic Stabilization System
Company
Highridge Medical, LLC
Model
07.01298.001
Catalog number
07.01298.001
Device description
Cord Tensioner
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NQPPOSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQPPosterior Metal/Polymer Spinal System, FusionOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663109864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663109864036626631098643662663109864

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation system cable tensionerA manual, hand-held surgical instrument used during orthopaedic surgery to apply an appropriate tension to a cable that is being implanted as part of a system to provide corrective surgery for the spine. The device is typically made of high-grade stainless steel, and is designed with a low intrusion profile to minimize the surgical exposure required for tightening the cables in situ. It will also be equipped with a means for accurate and reproducible tensioning of the cable(s). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-3625usbrocustomerservice@highridgemedical.com

Regulatory Flags#

DUNS number
119260394
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662663273350Timberline Lateral Fusion System8734-00308734-00302025-12-18
00887868381034Virage 3.0mm tapered Tap 14mm lengthLV01586LV015862026-04-30
00887868523083The TetherLV01666LV016662026-04-22
008884805002164.75mm Reamer ProbeLV00568LV005682026-04-15
00887868259814Radiolucent Pedicle ProbeLV01446LV014462026-04-07
03662663194457SC-AcuFix Anterior Cervical Plate System457-1457-12026-03-31
03662663194464SC-AcuFix Anterior Cervical Plate System474-1474-12026-03-31
03662663194471SC-AcuFix Anterior Cervical Plate System479-1479-12026-03-31
03662663199155Silhouette Spinal Fixation System7010-0003-007010-0003-002026-03-31
03662663199162Silhouette Spinal Fixation System7010-0011-007010-0011-002026-03-31
03662663199179Silhouette Spinal Fixation System7010-0013-007010-0013-002026-03-31
03662663199186Silhouette Spinal Fixation System7010-0014-007010-0014-002026-03-31
03662663199193Silhouette Spinal Fixation System7010-0015-007010-0015-002026-03-31
03662663199209Silhouette Spinal Fixation System7010-0084-007010-0084-002026-03-31
03662663199216Silhouette Spinal Fixation System7010-0133-007010-0133-002026-03-31
03662663199223Silhouette Spinal Fixation System7010-0152-017010-0152-012026-03-31
03662663130929Zyston Interbody Spacer System136M3306136M33062026-03-17
03662663130936Zyston Interbody Spacer System136M3307136M33072026-03-17
03662663131117Zyston Interbody Spacer System139M2606139M26062026-03-17
03662663136693Polaris 5.5 Spinal Fixation System14-50181014-5018102026-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20613994170174CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2016-07-08
00613994123732CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123749CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123800CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123824CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123831CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123909CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123916CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
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00613994188540CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
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00613994197412CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197429CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197344CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
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00613994197788CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197795CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197726CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-19
00613994197757CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-19
00613994177193CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188502CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188519CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188533CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188571CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18