MySpine

GUDID 07630040716505

MySpine LP drill pilot vertebra L04

Medacta International SA

Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 07630040716505
• NIH Device Record Key: 0c612407-4a49-4140-aaf8-2b89d97c69d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MySpine
• Version Model Number: 7.0454
• 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	07630040716505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153273

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

[07630040716505]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-22
• Device Publish Date: 2023-12-14

On-Brand Devices [MySpine]

• 07630040716888: MySpine LP drill pilot guide L05
• 07630040716864: MySpine LP drill pilot guide L04
• 07630040716840: MySpine LP drill pilot guide L03
• 07630040716826: MySpine LP drill pilot guide L02
• 07630040716802: MySpine LP drill pilot guide L01
• 07630040716789: MySpine LP drill pilot guide T12
• 07630040716765: MySpine LP drill pilot guide T11
• 07630040716741: MySpine LP drill pilot guide T10
• 07630040716727: MySpine LP drill pilot guide T09
• 07630040716703: MySpine LP drill pilot guide T08
• 07630040716680: MySpine LP drill pilot guide T07
• 07630040716666: MySpine LP drill pilot guide T06
• 07630040716642: MySpine LP drill pilot guide T05
• 07630040716628: MySpine LP drill pilot guide T04
• 07630040716604: MySpine LP drill pilot guide T03
• 07630040716581: MySpine LP drill pilot guide T02
• 07630040716567: MySpine LP drill pilot guide T01
• 07630971257870: MySpine-MC drill guide L06
• 07630971257832: MySpine-MC vertebra L06
• 07630040717571: MySpine-MC drill guide S01
• 07630040717557: MySpine-MC drill guide L05
• 07630040717533: MySpine-MC drill guide L04
• 07630040717519: MySpine-MC drill guide L03
• 07630040717496: MySpine-MC drill guide L02
• 07630040717472: MySpine-MC drill guide L01
• 07630040717458: MySpine-MC guide S01
• 07630040717434: MySpine-MC guide L05
• 07630040717410: MySpine-MC guide L04
• 07630040717397: MySpine-MC guide L03
• 07630040717373: MySpine-MC guide L02
• 07630040717359: MySpine-MC guide L01
• 07630040717335: MySpine-MC vertebra S01
• 07630040717311: MySpine-MC vertebra L05
• 07630040717298: MySpine-MC vertebra L04
• 07630040717274: MySpine-MC vertebra L03
• 07630040717250: MySpine-MCvertebra L02
• 07630040717236: MySpine-MC vertebra L01
• 07630971262737: MySpine LP drill pilot guide T13 STERILE
• 07630971262720: MySpine LP drill pilot guide T13
• 07630971257887: MySpine MC drill guide L06 STERILE
• 07630971257863: MySpine MC guide L06 STERILE
• 07630971257856: MySpine MC guide L06
• 07630971257849: MySpine MC vertebra L06 STERILE
• 07630971257825: MySpine LP drill pilot guide L06 STERILE
• 07630971257818: MySpine LP drill pilot guide L06
• 07630971257740: Full Spine Model Short
• 07630345752918: MySpine S2-SI right guide STE
• 07630345752901: MySpine S2-SI right guide
• 07630345752895: MySpine S2-SI left guide STE
• 07630345752888: MySpine S2-SI left guide