FDA.report

The Tether Vertebral Body Tethering System

Primary DI
03662663282154
Brand
The Tether Vertebral Body Tethering System
Company
Highridge Medical, LLC
Model
211H5545
Catalog number
211H5545
Device description
Vertebral Body Tethering Assembly, ΓΈ 5.5x45mm
Published
2026-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
QHPVertebral body tethering system

Product Code Classifications

CodeDeviceSpecialtyClass
QHPVertebral Body Tethering SystemUnknownN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663282154PrimaryGS10

GMDN Terms

TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep out of sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)447-3625usbrocustomerservice@highridgemedical.com

Regulatory Flags

DUNS number
119260394
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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03662663085458FlareHawkASY-00003ASY-000032025-10-03
03662663085502FlareHawkASY-00018ASY-000182025-10-03
03662663085533FlareHawkASY-00040ASY-000402025-10-03
03662663085540FlareHawkASY-00041ASY-000412025-10-03
03662663085632FlareHawkASY-00064ASY-000642025-10-03
03662663085663FlareHawkASY-00067ASY-000672025-10-03

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03662663282055The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282062The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
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03662663282130The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
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