VIA Spinous Process Fixation System 440-0034

GUDID M7404400034

15mm Rasp

SPINEOLOGY INC.

Bone file/rasp, manual, reusable
Primary Device IDM7404400034
NIH Device Record Key713706a0-9b5d-4dfb-8d3b-0fbcac5209fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIA Spinous Process Fixation System
Version Model Number34-06-17
Catalog Number440-0034
Company DUNS033014361
Company NameSPINEOLOGY INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com

Device Dimensions

Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0
Length15 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7404400034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEKSpinous process plate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


[M7404400034]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-23
Device Publish Date2015-02-25

On-Brand Devices [VIA Spinous Process Fixation System]

M7404400046Sterilzation Tray Base
M74044000427mm Dilator
M740440004117mm Modular Inserter
M740440004015mm Modular Inserter
M740440003913mm Modular Inserter
M740440003811mm Modular Inserter
M74044000379mm Modular Inserter
M7404400036Removal Tool
M740440003517mm Rasp
M740440003415mm Rasp
M740440003311mm Rasp
M74044000323" Distractor
M7404400030Final Tightner
M7404400028Implant Compressor
M7404400027Sterilzation Tray Base
M7404400026Sterilzation Pullout Tray
M7404400024Sterilization Lid
M7404400023Implant Inserter
M7404400022Implant Setting Block
M74044000215mm Dilator
M740440002013mm Rasp
M74044000199mm Rasp
M7404400018Trox Driver
M740440001517mm Trial
M740440001415mm Trial
M740440001313mm Trial
M740440001211mm Trial
M74044000119mm Trial
M7404400006Left and Right Female Plate
M7404400005Male Plate
M7404400004Male Plate
M7404400003Male Plate
M7404400002Male Plate
M7404400001Male Plate

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