OptiMesh Multiplanar Expandable Interbody Fusion System 311-0126

GUDID M743110126

Handheld Brace

SPINEOLOGY INC.

Surgical instrument assist arm system, manually-adjusted

• Primary Device ID: M743110126
• NIH Device Record Key: 8396c402-a78e-4107-b042-e9f3bb9c9aca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiMesh Multiplanar Expandable Interbody Fusion System
• Version Model Number: 32-27-47
• Catalog Number: 311-0126
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M743110126 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

[M743110126]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-22
• Device Publish Date: 2023-09-14

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

• 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