My Spine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides

GUDID 07630040728355

MySpine S02 right guide sterile

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630040728355
• NIH Device Record Key: ef166498-4b8a-4ced-9f47-0ca4dc99105b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Spine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
• Version Model Number: 7.0728S
• 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	07630040728355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200792

FDA Product Code

• PQC: Pedicle Screw Placement Guide

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-16
• Device Publish Date: 2020-10-08

On-Brand Devices [My Spine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides]

• 07630971255791: MySpine S02 left guide sterile
• 07630971255784: MySpine S02 left guide
• 07630971255777: MySpine S02 vertebra sterile
• 07630971255760: MySpine S02 vertebra
• 07630040728355: MySpine S02 right guide sterile
• 07630040728348: MySpine S02 right guide