OptiMesh Multiplanar Expandable Interbody Fusion System 330-0022

GUDID M7403300022

Polymeric spinal interbody fusion cage

Primary Device ID	M7403300022
NIH Device Record Key	46b29a4e-4ce6-4773-888f-ad7d40409e6a
Commercial Distribution Status	In Commercial Distribution
Brand Name	OptiMesh Multiplanar Expandable Interbody Fusion System
Version Model Number	35-06-72
Catalog Number	330-0022
Company DUNS	033014361
Company Name	SPINEOLOGY INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	M7403300022 [Primary]

LXH	Orthopedic Manual Surgical Instrument

Steralize Prior To Use	false
Device Is Sterile	true

M7403150025	Powered Bent Brush
M7403150024	Manual Bent Tissue Extractor Brush
M749000024	Palm Handle
M743120057	Push Rod
M743120056	Graft Tube
M743120053	Shaper Handle
M743120052	Lock Box
M743120051	QuikTrak
M743120050	Shaper Body
M743120049	Portal Head
M743120047	Reverse Articulating Curette
M743120041	I-Beam
M743120037	Table Arm
M743120036	Table Post
M743120028	Short Articulating Curette
M743120021	Tube Ejector
M743120019	Stopped Pituitary Rongeur
M743120014	Dilator One
M743120011	Drilling Dilator
M743110126	Handheld Brace
M743110100	Articulating Curette
M7403150016	E Portal Tube
M7403120054	Drill
M7403120048	Portal Stem
M7403120045	Transiliac Drill
M7403120044	Short Portal Stem
M7403120039	Suction Tube
M7403120024	Portal Impactor
M7403120018	Dilator Two
M7403120016	Dilator Impactor
M7403120013	Non-Cannulated Dilator One
M7403120002	Mallet
M7403100009	Pin Introducer, 11g X 15cm Diamond
M7403100008	Pin Introducer, 11g X 15cm Bevel
M7403010156	Spineology Jackson Table Rail/Bracket
M7403010021	Push Rod
M7403001011	Guide Pin, Round/Round, 2.4mm Dia. X 508mm Long
M7403001010	Guide Pin, Trocar/Round, 2.4mm Dia. X 508mm Long
M7409000024	Palm Handle
M7403120057	Push Rod
M7403120056	Graft Tube
M7403120053	Shaper Handle
M7403120052	Lock Box
M7403120051	QuikTrak
M7403120050	Shaper Body
M7403120049	Portal Head
M7403120047	Reverse Articulating Curette
M7403120041	I-Beam
M7403120037	Table Arm
M7403120036	Table Post