LUMIS™

GUDID 03663136006949

MULTI-AXIAL SCREW, DIAMETER 5.5mm, LENGTH 45mm

SPINEVISION

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 03663136006949
• NIH Device Record Key: 6c71fe5a-157d-4e02-a0b4-bd3ce9b14f22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMIS™
• Version Model Number: MS1-M545T
• Company DUNS: 390377518
• Company Name: SPINEVISION
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663136006949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112607

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[03663136006949]

Moist Heat or Steam Sterilization

[03663136006949]

Moist Heat or Steam Sterilization

[03663136006949]

Moist Heat or Steam Sterilization

[03663136006949]

Moist Heat or Steam Sterilization

[03663136006949]

Moist Heat or Steam Sterilization

[03663136006949]

Moist Heat or Steam Sterilization

[03663136006949]

Moist Heat or Steam Sterilization

[03663136006949]

Moist Heat or Steam Sterilization

[03663136006949]

Moist Heat or Steam Sterilization

[03663136006949]

Moist Heat or Steam Sterilization

[03663136006949]

Moist Heat or Steam Sterilization

[03663136006949]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-12-20
• Device Publish Date: 2015-10-15

On-Brand Devices [LUMIS™]

• 03663136020181: Ti 6.0 mm x 135 mm PRE-BENT PERCUTANEOUS ROD
• 03663136018782: Ø8mm CANNULATED TAP
• 03663136007809: MULTI-AXIAL SCREW Ø 8.5mm L 60mm
• 03663136007670: MULTI-AXIAL SCREW Ø 6.5mm L 55mm
• 03663136006949: MULTI-AXIAL SCREW, DIAMETER 5.5mm, LENGTH 45mm
• 03663136006925: MULTI-AXIAL SCREW, DIAMETER 5.5mm, LENGTH 35mm