UNI-THREAD®

GUDID 03663136006222

Ti 5.5 mm x 33-38mm threaded reduction screw,6.5mm top

SPINEVISION

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 03663136006222
• NIH Device Record Key: 28a4ac87-773a-47a9-b889-afc9daa6d645
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNI-THREAD®
• Version Model Number: L2-SH538T
• 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	03663136006222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013301

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[03663136006222]

Moist Heat or Steam Sterilization

[03663136006222]

Moist Heat or Steam Sterilization

[03663136006222]

Moist Heat or Steam Sterilization

[03663136006222]

Moist Heat or Steam Sterilization

[03663136006222]

Moist Heat or Steam Sterilization

[03663136006222]

Moist Heat or Steam Sterilization

[03663136006222]

Moist Heat or Steam Sterilization

[03663136006222]

Moist Heat or Steam Sterilization

[03663136006222]

Moist Heat or Steam Sterilization

[03663136006222]

Moist Heat or Steam Sterilization

[03663136006222]

Moist Heat or Steam Sterilization

[03663136006222]

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 [UNI-THREAD®]

• 03663136027258: Upper Arm
• 03663136027135: BLADE HOLDER 2
• 03663136020044: Ti 6.5mm x 120mm Right Reduction Rod Connector
• 03663136020006: Ti 6.5mm x 60mm Right Reduction Rod Connector
• 03663136006222: Ti 5.5 mm x 33-38mm threaded reduction screw,6.5mm top
• 03663136005867: Ti 6.5mm x 40mm Right Rod Connector
• 03663136005584: Ti 6.0 mm x 80 mm pre-bent rod