M.U.S.T. Set Screw

GUDID 07630030885440

Connector Setscrew (2x)

Medacta International SA

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 07630030885440
• NIH Device Record Key: 59bbf715-47f4-4d48-af26-3d365c276159
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M.U.S.T. Set Screw
• Version Model Number: 03.56.212
• 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	07630030885440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162061

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

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. Set Screw ]

• 07630030885440: Connector Setscrew (2x)
• 07630030885433: Connector Setscrew (1x)
• 07630030834844: Set screw (1x) Sterile