restor3d Lumbar Instrumentation

GUDID 00840097509990

ALIF Disc Prep - Level 3

Restor3d, Inc.

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 00840097509990
• NIH Device Record Key: 23430ae6-a24a-4591-8c92-5cf28729f0a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Lumbar Instrumentation
• Version Model Number: 5113-B0013
• Company DUNS: 080819836
• Company Name: Restor3d, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097509990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234087

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

[00840097509990]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [restor3d Lumbar Instrumentation]

• 00840097509990: ALIF Disc Prep - Level 3
• 00840097509983: ALIF Disc Prep - Level 2
• 00840097509976: ALIF Disc Prep - Level 1
• 00840097509969: ALIF Disc Prep - Lid
• 00840097509952: ALIF Disc Prep - Case
• 00840097509730: Large Cobb Angled 28mm
• 00840097509723: Small Cobb Angled 22mm
• 00840097509716: Large Cobb Straight 28mm
• 00840097509709: Small Cobb Straight 22mm
• 00840097509693: Osteotome Angled 15mm
• 00840097509686: Osteotome Straight 15mm
• 00840097509679: Nerve Root Probe
• 00840097509662: Nerve Hook
• 00840097509655: Push Curette (Elephant foot)
• 00840097509648: Ring Curette Stirrup Up
• 00840097509631: Ring Curette Stirrup Straight
• 00840097509624: Cup 5 Curette Up
• 00840097509617: Cup 2 Curette Up
• 00840097509600: Cup 5 Curette Straight
• 00840097509594: Cup 2 Curette Straight
• 00840097509587: Rasp Angled Double Sided
• 00840097509570: Rasp Straight Double Sided
• 00840097509563: Bone Rongeur 8mm Double Action
• 00840097509556: Kerrison Rongeur Straight 6mm, 13"
• 00840097509549: Kerrison Rongeur Straight 4mm, 13"
• 00840097509532: Kerrison Rongeur Straight 2mm, 13"
• 00840097505305: Pituitary Rongeur Straight 6mm, 13"
• 00840097505299: Pituitary Rongeur Straight 4mm, 13"
• 00840097505282: Scalpel Handle Long 15"