My Spine Placement Guides

GUDID 07630971262676

MySpine drill guide T13 STERILE

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630971262676
• NIH Device Record Key: 0524ca42-7223-4732-89bb-466173cd77dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Spine Placement Guides
• Version Model Number: 7.0113S
• 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	07630971262676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132788

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

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: 2022-02-18
• Device Publish Date: 2022-02-10

On-Brand Devices [My Spine Placement Guides]

• 07630971262744: MySpine vertebra T13
• 07630971262676: MySpine drill guide T13 STERILE
• 07630971262669: MySpine drill guide T13
• 07630971262577: MySpine vertebra T13 STERILE
• 07630971257764: MySpine drill guide L06 STERILE
• 07630971257757: MySpine drill guide L06
• 07630971257733: MySpine vertebra L06 STERILE
• 07630971257726: MySpine vertebra L06