FDA.reportPublic FDA data

The Tether™

Primary DI
00887868227455
Brand
The Tether™
Company
ZIMMER BIOMET INC
Model
230H6003
Device description
CORD TENSIONER
Published
2019-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

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
00887868227455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868227455008878682274558878682274550887868227455

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
045576443
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888480511557Lineum®14-52505314-5250532020-07-07
00887868289163Virage® OCT07.01770.00107.01770.0012020-02-13
00887868289170Virage®07.01771.00207.01771.0022020-02-13
00887868289187Virage®07.01772.00207.01772.0022020-02-13
00887868289194Virage®07.01773.00207.01773.0022020-02-13
00887868289385Virage® OCT07.01803.00107.01803.0012020-02-13
00887868244728Vital™730M0011730M00112019-06-04
00887868244735Vital™730M0012730M00122019-06-04
03662663063081Vital Spinal Fixation System710M11562024-06-26
03662663063098Vital Spinal Fixation System710M12562024-06-26
03662663063104Vital Spinal Fixation System710M13562024-06-26
03662663063111Vital Spinal Fixation System710M14562024-06-26
03662663063128Vital Spinal Fixation System710M15562024-06-26
03662663063135Vital Spinal Fixation System710M17562024-06-26
00887868528774VItal Spinal Fixation System850M00302024-06-11
00887868528781VItal Spinal Fixation System850M00312024-06-11
00887868528798VItal Spinal Fixation System850M00322024-06-11
00887868528804VItal Spinal Fixation System850M00332024-06-11
00887868528811VItal Spinal Fixation System850M00342024-06-11
00887868528828VItal Spinal Fixation System850M00352024-06-11

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