FDA.reportPublic FDA data

The Tether Vertebral Body Tethering System

Primary DI
00887868227370
Brand
The Tether Vertebral Body Tethering System
Company
Highridge Medical, LLC
Model
230H2001
Catalog number
230H2001
Device description
Anchor Inserter Outer DTS
Published
2019-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QHPVertebral Body Tethering System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QHPVertebral Body Tethering SystemUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868227370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868227370008878682273708878682273700887868227370

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
03662663282055The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282062The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282079The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282086The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282093The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282109The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282116The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282123The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282130The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282147The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282154The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282161The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282178The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282185The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282192The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282208The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282215The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282222The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282239The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282246The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282253The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282260The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282277The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282314The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282321The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282338The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282345The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282352The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282369The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282376The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16