Duo Lumbar Interbody Fusion System 100-1028

GUDID M7401001028

Duo Trial, 12mm, 8°

SPINEOLOGY INC.

Polymeric spinal fusion cage, sterile
Primary Device IDM7401001028
NIH Device Record Key6f650e84-2755-4390-8757-a9df5c38c839
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuo Lumbar Interbody Fusion System
Version Model Number101-56-02-12
Catalog Number100-1028
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
Emailaadams@spineology.com

Device Dimensions

Height12 Millimeter
Height12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7401001028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7401001028]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-03
Device Publish Date2019-03-26

On-Brand Devices [Duo Lumbar Interbody Fusion System]

M7401001030Duo Trial, 16mm, 8°
M7401001029Duo Trial, 14mm, 8°
M7401001028Duo Trial, 12mm, 8°
M7401001027Duo Trial, 10mm, 8°
M7408608110Duo LU Angled Trial, 14mm, 15°
M7408608109Duo LU Angled Trial, 12mm, 15°
M7408608103Duo LU Angled Trial, 16mm, 8°
M7408608102Duo LU Angled Trial, 14mm, 8°
M7408608101Duo LU Angled Trial, 12mm, 8°
M7408608100Duo LU Angled Trial, 10mm, 8°
M7408608008Duo Angled Trial, 16mm, 0°
M7408608007Duo Angled Trial, 14mm, 0°
M7408608006Duo Angled Trial, 12mm, 0°
M7408608005Duo Angled Trial, 10mm, 0°
M7408608004Duo Angled Trial, 8mm, 0°
M7408600519Duo Angled Inserter Fork
M7408600515Duo Angled Access Inserter
M7401001113Duo Angled Inserter Fork
M7401001112Duo Straight Inserter Fork

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.