Duo Ti Expandable Interbody Fusion System 297-6012

GUDID M7402976012

Duo Ti, 60 x 12mm, 15°

SPINEOLOGY INC.

Metallic spinal interbody fusion cage
Primary Device IDM7402976012
NIH Device Record Key4316c72a-816b-4a7b-aae2-c21d0718021c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuo Ti Expandable Interbody Fusion System
Version Model Number86-12-03-10
Catalog Number297-6012
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
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7402976012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-15
Device Publish Date2021-10-07

On-Brand Devices [Duo Ti Expandable Interbody Fusion System]

M7408610048Duo Ti Angled Trial, 16mm, 15°
M7408610047Duo Ti Angled Trial, 14mm, 15°
M7408610046Duo Ti Angled Trial, 12mm, 15°
M7408610045Duo Ti Angled Trial, 16mm, 8°
M7408610044Duo Ti Angled Trial, 14mm, 8°
M7408610043Duo Ti Angled Trial, 12mm, 8°
M7408610042Duo Ti Angled Trial, 10mm, 8°
M7408610041Duo Ti Angled Trial, 16mm, 0°
M7408610040Duo Ti Angled Trial, 14mm, 0°
M7408610039Duo Ti Angled Trial, 12mm, 0°
M7408610038Duo Ti Angled Trial, 10mm, 0°
M7408610037Duo Ti Angled Trial, 8mm, 0°
M7408610036Duo Ti Trial, 16mm, 15°
M7408610035Duo Ti Trial, 14mm, 15°
M7408610034Duo Ti Trial, 12mm, 15°
M7408610033Duo Ti Trial, 16mm, 8°
M7408610032Duo Ti Trial, 14mm, 8°
M7408610031Duo Ti Trial, 12mm, 8°
M7408610030Duo Ti Trial, 10mm, 8°
M7408610029Duo Ti Trial, 16mm, 0°
M7408610028Duo Ti Trial, 14mm, 0°
M7408610027Duo Ti Trial, 12mm, 0°
M7408610026Duo Ti Trial, 10mm, 0°
M7408610025Duo Ti Trial, 8mm, 0°
M7402976016Duo Ti, 60 x 16mm, 15°
M7402976014Duo Ti, 60 x 14mm, 15°
M7402976012Duo Ti, 60 x 12mm, 15°
M7402975516Duo Ti, 55 x 16mm, 15°
M7402975514Duo Ti, 55 x 14mm, 15°
M7402975512Duo Ti, 55 x 12mm, 15°
M7402975016Duo Ti, 50 x 16mm, 15°
M7402975014Duo Ti, 50 x 14mm, 15°
M7402975012Duo Ti, 50 x 12mm, 15°
M7402974516Duo Ti, 45 x 16mm, 15°
M7402974514Duo Ti, 45 x 14mm, 15°
M7402974512Duo Ti, 45 x 12mm, 15°
M7402966016Duo Ti, 60 x 16mm, 8°
M7402966014Duo Ti, 60 x 14mm, 8°
M7402966012Duo Ti, 60 x 12mm, 8°
M7402966010Duo Ti, 60 x 10mm, 8°
M7402965516Duo Ti, 55 x 16mm, 8°
M7402965514Duo Ti, 55 x 14mm, 8°
M7402965512Duo Ti, 55 x 12mm, 8°
M7402965510Duo Ti, 55 x 10mm, 8°
M7402965016Duo Ti, 50 x 16mm, 8°
M7402965014Duo Ti, 50 x 14mm, 8°
M7402965012Duo Ti, 50 x 12mm, 8°
M7402965010Duo Ti, 50 x 10mm, 8°
M7402964516Duo Ti, 45 x 16mm, 8°
M7402964514Duo Ti, 45 x 14mm, 8°
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