M.U.S.T. MINI Rod

GUDID 07630030865053

Rod CoCr ø3.5 x 350mm (sterile)

Medacta International SA

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 07630030865053
• NIH Device Record Key: 79924402-4954-4fb8-ab6e-549226414206
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M.U.S.T. MINI Rod
• Version Model Number: 03.75.607
• 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	07630030865053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171369

FDA Product Code

• NKG: Orthosis, Cervical Pedicle Screw Spinal 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-20

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

• 07630030865084: Transition Rod CoCr ø3.5/ø5.5x420(sterile)
• 07630030865060: Transition Rod Ti ø3.5/ø5.5x420(sterile)
• 07630030865053: Rod CoCr ø3.5 x 350mm (sterile)
• 07630030865046: Rod CoCr ø3.5 x 240mm (sterile)
• 07630030865039: Rod CoCr ø3.5 x 120mm (sterile)
• 07630030865022: Rod CoCr ø3.5 x 80mm (sterile)
• 07630030865015: Rod Ti ø3.5 x 350mm (sterile)
• 07630030865008: Rod Ti ø3.5 x 240mm (sterile)
• 07630030864995: Rod Ti ø3.5 x 120mm (sterile)
• 07630030864988: Rod Ti ø3.5 x 80mm (sterile)