FDA.reportPublic FDA data

Dynesys Dynamic Stabilization System

Primary DI
00887868287213
Brand
Dynesys Dynamic Stabilization System
Company
Highridge Medical, LLC
Model
07.00874.002
Catalog number
07.00874.002
Device description
Screw Retainer
Published
2025-11-12
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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868287213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868287213008878682872138878682872130887868287213

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. 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
Premarket exempt
true
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
00198506091339ELMED INCORPORATEDELMED INCORPORATEDGAD2026-06-09
00840277133670Innomed, Inc.INNOMED, INC.GAD2026-06-09
04049047155324GimmiGimmi GmbHGAD2026-06-08
G453PM1580030BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-06-08
00846159040524SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040531SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040548SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040555SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040562SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040579SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040586SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
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00846159040623SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00841536147230ThompsonThompson Surgical Instruments, Inc.GAD2026-06-03
00846159040388SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040395SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040401SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040418SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040425SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040432SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040449SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040456SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040463SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040470SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040487SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040494SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040500SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040517SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03