FDA.reportPublic FDA data

The Tether™

Primary DI
00887868227387
Brand
The Tether™
Company
ZIMMER BIOMET INC
Model
230H2002
Device description
ANCHOR INSERTER INNER DTS
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
00887868227387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868227387008878682273878878682273870887868227387

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

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