Threshold Pedicular Fixation System 530-0034

GUDID M7405300034

Counter Torque

SPINEOLOGY INC.

Orthopaedic counter-torque/rod-pushing instrument
Primary Device IDM7405300034
NIH Device Record Key98e01489-ebf6-4eee-be7f-27302a71480e
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreshold Pedicular Fixation System
Version Model Number53-10-11
Catalog Number530-0034
Company DUNS033014361
Company NameSPINEOLOGY INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7405300034 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

[M7405300034]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-15
Device Publish Date2024-01-05

On-Brand Devices [Threshold Pedicular Fixation System]

M7405300097Tower Wrench
M7405300096Tower Socket
M7405300095Fixed Jaws
M7405300094Fixed Rod Holder
M7405300047Distractor
M7405300046Compressor
M7405300044Open Counter Torque
M7405300043Final Driver (S/N: )
M7405300040Internal Rod Reducer
M7405300037Set Screw Placer
M7405300036Extension Reattachment
M7405300034Counter Torque
M7405300033Extension Pivot
M7405300031External Reducer
M7405300016Dilator Four
M7405300015Dilator Three
M7405300014Dilator Three (threaded)
M7405300013Dilator Two
M7405300012Dilator One
M7405300006Cannulated Rod Pusher
M7405300005AWL Handle
M7405300004AWL Cap
M7405300003AWL Stylet
M7405300002Cannulated AWL Shaft
M7405500045Rod Bender
M7405501500Straight Rod
M7405501400Straight Rod
M7405500200Straight Rod
M7405500180Straight Rod
M7405500160Straight Rod
M7405500140Straight Rod
M7405500120Straight Rod
M7405500100Straight Rod
M7405300041Ratcheting Axial Handle
M7405300091NiTi Guide Pin, 1.4mm x 610mm Blunt
M7405300090NiTi Guide Pin, 1.4mm x 610mm Trocar/Round
M7405300089Guide Pin, 1.4mm x 508mm Trocar/Round
M7405300088Guide Pin, 1.4mm x 508mm Trocar/Round Threaded
M7405300087Guide Pin, 1.4mm x 508mm Round/Round
M7405530043In-Situ Bender
M7405530042In-Situ Bender
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