FDA.reportPublic FDA data

The Tether Vertebral Body Tethering System

Primary DI
03662663192323
Brand
The Tether Vertebral Body Tethering System
Company
Highridge Medical, LLC
Model
200H3102
Catalog number
200H3102
Device description
Implant Tote
Published
2025-12-17
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
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663192323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663192323036626631923233662663192323

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
07649988948725SPIRECUTSPIRECUT SALRP2026-05-04
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G141588222990Carnegie Surgical LLCCarnegie Surgical LLCLRP2023-02-13
07899798205796QuinelatoSchobell Industrial LtdaLRP2022-12-20
10080196055159MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196818778MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196848041MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196996681MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10190001934897MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190021MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
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10193489191240MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190199MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190205MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190212MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
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