Diverted Bone Tube 101-1081

GUDID M7401011081

SPINEOLOGY INC.

Polymeric spinal interbody fusion cage
Primary Device IDM7401011081
NIH Device Record Keye943e96e-0f7b-44ee-b4ff-6b48bc3eec59
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiverted Bone Tube
Version Model Number102-11-100
Catalog Number101-1081
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 Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7401011081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQBIntervertebral Body Graft Containment Device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7401011081]

Moist Heat or Steam Sterilization


[M7401011081]

Moist Heat or Steam Sterilization


[M7401011081]

Moist Heat or Steam Sterilization


[M7401011081]

Moist Heat or Steam Sterilization


[M7401011081]

Moist Heat or Steam Sterilization


[M7401011081]

Moist Heat or Steam Sterilization


[M7401011081]

Moist Heat or Steam Sterilization


[M7401011081]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-30
Device Publish Date2022-06-22

Devices Manufactured by SPINEOLOGY INC.

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M7401001300 - Threshold V2 Pedicular Fixation System2025-07-10 Straight Lumbar Probe
M7401001301 - Threshold V2 Pedicular Fixation System2025-07-10 Curved Duckbill Probe
M7401001336 - OptiMesh Multiplanar Expandable Interbody Fusion System2025-07-08 TLIF Portal Anchor, Midline 4mm
M7401001338 - OptiMesh Multiplanar Expandable Interbody Fusion System2025-07-08 TLIF Portal Anchor, Angled 4mm
M7401001339 - OptiMesh Multiplanar Expandable Interbody Fusion System2025-07-08 Modified Portal Stem
M7401001342 - OptiMesh Multiplanar Expandable Interbody Fusion System2025-07-08 Universal 2.0 Inserter Ref. Assembly

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