ROMEO 2 PAD POSTERIOR AXIAL DEVICE

GUDID 07640151087593

Posterior Axial Device - Titanium

SpineArt SA

Interspinous spinal fixation implant

• Primary Device ID: 07640151087593
• NIH Device Record Key: da7e6636-f33a-4078-a8ad-c4b04fc3c479
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMEO 2 PAD POSTERIOR AXIAL DEVICE
• Version Model Number: PAD-IM TI 10-S
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	07640151087593 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141508

FDA Product Code

• PEK: Spinous Process Plate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2015-10-06

On-Brand Devices [ROMEO 2 PAD POSTERIOR AXIAL DEVICE]

• 07640151087630: Posterior Axial Device - Titanium
• 07640151087623: Posterior Axial Device - Titanium
• 07640151087616: Posterior Axial Device - Titanium
• 07640151087609: Posterior Axial Device - Titanium
• 07640151087593: Posterior Axial Device - Titanium
• 07640151087586: Posterior Axial Device - Titanium