OptiMesh Multiplanar Expandable Interbody Fusion System 100-0490

GUDID M7401000490

5.5mm Rod Hand Brace

SPINEOLOGY INC.

Surgical instrument assist arm system, manually-adjusted
Primary Device IDM7401000490
NIH Device Record Keyf62866f2-f7ea-490d-870b-02f403457a02
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiMesh Multiplanar Expandable Interbody Fusion System
Version Model Number102-54-01
Catalog Number100-0490
Company DUNS033014361
Company NameSPINEOLOGY INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

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 Dimensions

Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7401000490 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

[M7401000490]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-14
Device Publish Date2024-08-06

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

M7403150025Powered Bent Brush
M7403150024Manual Bent Tissue Extractor Brush
M749000024Palm Handle
M743120057Push Rod
M743120056Graft Tube
M743120053Shaper Handle
M743120052Lock Box
M743120051QuikTrak
M743120050Shaper Body
M743120049Portal Head
M743120047Reverse Articulating Curette
M743120041I-Beam
M743120037Table Arm
M743120036Table Post
M743120028Short Articulating Curette
M743120021Tube Ejector
M743120019Stopped Pituitary Rongeur
M743120014Dilator One
M743120011Drilling Dilator
M743110126Handheld Brace
M743110100Articulating Curette
M7403150016E Portal Tube
M7403120054Drill
M7403120048Portal Stem
M7403120045Transiliac Drill
M7403120044Short Portal Stem
M7403120039Suction Tube
M7403120024Portal Impactor
M7403120018Dilator Two
M7403120016Dilator Impactor
M7403120013Non-Cannulated Dilator One
M7403120002Mallet
M7403100009Pin Introducer, 11g X 15cm Diamond
M7403100008Pin Introducer, 11g X 15cm Bevel
M7403010156Spineology Jackson Table Rail/Bracket
M7403010021Push Rod
M7403001011Guide Pin, Round/Round, 2.4mm Dia. X 508mm Long
M7403001010Guide Pin, Trocar/Round, 2.4mm Dia. X 508mm Long
M7409000024Palm Handle
M7403120057Push Rod
M7403120056Graft Tube
M7403120053Shaper Handle
M7403120052Lock Box
M7403120051QuikTrak
M7403120050Shaper Body
M7403120049Portal Head
M7403120047Reverse Articulating Curette
M7403120041I-Beam
M7403120037Table Arm
M7403120036Table Post
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.