M.U.S.T. Reduction Pedicle Screw

GUDID 07630030884498

Red. Cann. Ped. Scr. 4.5 x 40mm Sterile

Medacta International SA

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 07630030884498
• NIH Device Record Key: 18dbaf60-060f-415a-bf53-eb2b8ebfac4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M.U.S.T. Reduction Pedicle Screw
• Version Model Number: 03.52.705
• 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	07630030884498 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171170

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

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: 2017-08-24

On-Brand Devices [M.U.S.T. Reduction Pedicle Screw ]

• 07630030884511: Red. Cann. Ped. Scr. 4.5 x 50mm Sterile
• 07630030884504: Red. Cann. Ped. Scr. 4.5 x 45mm Sterile
• 07630030884498: Red. Cann. Ped. Scr. 4.5 x 40mm Sterile
• 07630030884481: Red. Cann. Ped. Scr. 4.5 x 35mm Sterile
• 07630030884474: Red. Cann. Ped. Scr. 4.5 x 30mm Sterile
• 07630030884467: Red. Cann. Ped. Scr. 4.5 x 25mm Sterile
• 07630030884450: Red. Cann. Ped. Scr. 4.5 x 20mm Sterile
• 07630030884375: Reduct. Ped. Scr. 4.0 x 50mm - Sterile
• 07630030884368: Reduct. Ped. Scr. 4.0 x 45mm - Sterile
• 07630030884351: Reduct. Ped. Scr. 4.0 x 40mm - Sterile
• 07630030884344: Reduct. Ped. Scr. 4.0 x 35mm - Sterile
• 07630030884337: Reduct. Ped. Scr. 4.0 x 30mm - Sterile
• 07630030884320: Reduct. Ped. Scr. 4.0 x 25mm - Sterile
• 07630030884313: Reduct. Ped. Scr. 4.0 x 20mm - Sterile