OptiMesh Expandable Interbody Fusion System 312-0004

GUDID M7403120004

Release Driver

SPINEOLOGY INC.

Polymeric spinal interbody fusion cage
Primary Device IDM7403120004
NIH Device Record Key2c82d0ec-c6f5-41f1-8af5-6716c23a0248
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiMesh Expandable Interbody Fusion System
Version Model Number32-01-28
Catalog Number312-0004
Company DUNS033014361
Company NameSPINEOLOGY INC.
Device Count1
DM Exemptfalse
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 Datefalse
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
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 Identifiers

Device Issuing AgencyDevice ID
HIBCCM7403120004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQBIntervertebral Body Graft Containment Device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


[M7403120004]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-25
Device Publish Date2021-03-17

On-Brand Devices [OptiMesh Expandable Interbody Fusion System]

M7403120055Mesh Extender
M7403120004Release Driver
M7403120003Tube Twister
M7403120001Inserter
M7403003440OptiMesh
M7403003032OptiMesh
M7403002628OptiMesh
M7403001012Diverted Fill Tube
M7403001008Straight Fill Tube
M7403001015Diverted Fill Tube

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