Virage OCT Spinal Fixation System 300P0009

GUDID 03662663080088

Channel Connector (Ø3.5mm/4.0mm - Ø5.5mm/6.0mm)

Highridge Medical, LLC

Bone-screw internal spinal fixation system connector
Primary Device ID03662663080088
NIH Device Record Key3e967cdd-7e14-4823-b31b-955c94148fe2
Commercial Distribution StatusIn Commercial Distribution
Brand NameVirage OCT Spinal Fixation System
Version Model Number300P0009
Catalog Number300P0009
Company DUNS119260394
Company NameHighridge Medical, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103662663080088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


[03662663080088]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-02
Device Publish Date2025-04-24

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00887868459085 - Long Vitality Rocket Reducer2025-05-07 Long Vital Rocket Reducer
00887868522703 - T27 Special Starter Driver (Short)2025-05-07 T27 Special Starter Driver (Short)
00888480588177 - 1/4 Square Adaptor2025-05-07 1/4 SQUARE ADAPTOR
03662663055185 - SHORT UNIPLANAR SHAFT2025-05-07 SHORT UNIPLANAR SHAFT
00880304855397 - Distraction Tube - Left2025-05-05 DISTRACTION TUBE - LEFT
00887868456657 - Puros-P Inserter2025-05-05 Puros-P Inserter

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