OptiMesh HA Nano Multiplanar Expandable Interbody Fusion System 500-3032

GUDID M7405003032

OptiMesh HA Nano, Medium

SPINEOLOGY INC.

Polymeric spinal interbody fusion cage
Primary Device IDM7405003032
NIH Device Record Key82223b23-2c06-40de-9c88-20ac02eb23a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiMesh HA Nano Multiplanar Expandable Interbody Fusion System
Version Model Number32-01-37-2
Catalog Number500-3032
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 Usetrue
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

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
HIBCCM7405003032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQBIntervertebral Body Graft Containment Device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-29
Device Publish Date2025-12-19

On-Brand Devices [OptiMesh HA Nano Multiplanar Expandable Interbody Fusion System]

M7405003440OptiMesh HA Nano, Large
M7405003032OptiMesh HA Nano, Medium
M7405002628OptiMesh HA Nano, Small

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