M.U.S.T. Anodized Rod

GUDID 07630030877292

Enhanced Anodized Rod Ti 5.5x100

Medacta International SA

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 07630030877292
• NIH Device Record Key: 40c31b66-4139-4266-bb62-739de9430858
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M.U.S.T. Anodized Rod
• Version Model Number: 03.52.814
• Company DUNS: 488227125
• Company Name: Medacta International 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	07630030877292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162061

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-09

On-Brand Devices [M.U.S.T. Anodized Rod]

• 07630030877322: Enhanced Anodized Rod Ti 5.5x480
• 07630030877315: Enhanced Anodized Rod Ti 5.5x300
• 07630030877308: Enhanced Anodized Rod Ti 5.5x200
• 07630030877292: Enhanced Anodized Rod Ti 5.5x100
• 07630030877278: Enhanced Anodized Rod Ti 5.5x480 - Unsterile
• 07630030877261: Enhanced Anodized Rod Ti 5.5x300 - Unsterile
• 07630030877254: Enhanced Anodized Rod Ti 5.5x200 - Unsterile
• 07630030877247: Enhanced Anodized Rod Ti 5.5x100 - Unsterile
• 07630030861499: Anodized Rod Ti 5.5x480 - Unsterile
• 07630030861482: Anodized Rod Ti 5.5x300 - Unsterile
• 07630030861475: Anodized Rod Ti 5.5x200 - Unsterile
• 07630030861468: Anodized Rod Ti 5.5x100 - Unsterile
• 07630030861338: Anodized Rod Ti 5.5x480
• 07630030861321: Anodized Rod Ti 5.5x300
• 07630030861314: Anodized Rod Ti 5.5x200
• 07630030861307: Anodized Rod Ti 5.5x100