UNI-THREAD®

GUDID 03663136019765

M6 plug

SPINEVISION

Spinal bone set screw

• Primary Device ID: 03663136019765
• NIH Device Record Key: 35c8b179-c30c-471d-8cca-4236a37530a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNI-THREAD®
• Version Model Number: L2-L200T
• 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663136019765 [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

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

[03663136019765]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-01-15
• 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
• 03663136006109: Ti 6.5 mm x 43-48 mm screw
• 03663136006093: Ti 6.5 mm x 38-43 mm screw
• 03663136006048: Ti 5.5mm x 43-48 mm Screw
• 03663136005874: Ti 6.5mm x 80mm Left Rod Connector
• 03663136005638: Ti 6.0 mm x 90 mm rod
• 03663136004754: Ti 5.5 mm x 53-58 mm screw with cylindrical post
• 03663136019956: Ti 6.5mm x 120mm Left Reduction Rod Connector
• 03663136005348: Ti 7.5 mm Reduction Connector
• 03663136027500: Ti UNI-THREAD IMPLANT SUPPORT
• 03663136027494: LOWER TRAY FOR LOMBAR RACK
• 03663136027487: UPPER TRAY FOR LOMBAR RACK
• 03663136027470: LID FOR LUMBAR RACK
• 03663136027463: RACK FOR REDUCTION IMPLANT
• 03663136027456: BASE FOR REDUCTION CONTAINER
• 03663136027449: Ti UniThread Implant Insert
• 03663136027432: Rack for LIS
• 03663136027425: Container for LIS
• 03663136027418: RACK FOR REDUCTION IMPLANT
• 03663136027401: MAT FOR REDUCTION CONTAINER
• 03663136027302: Connector template
• 03663136027227: Lower Arm
• 03663136027197: BLADE HOLDER
• 03663136027180: Vis M3 x 9,5mm
• 03663136027159: BLADE 50mm
• 03663136026985: LIS Blade R 70mm
• 03663136026855: CANNULATED SCREWDRIVER SHAFT
• 03663136026800: BEERE HANDLE
• 03663136026787: Pin Ø1.8mm x 510mm
• 03663136026725: Long T20 Holder Shaft
• 03663136026633: Pedicle screwdriver shaft
• 03663136026558: Screw post collector
• 03663136026459: Rod connector gripper
• 03663136026435: Connector holder
• 03663136026398: Pedicle Marker Holder
• 03663136005911: Ti 6.5mm x 40mm Left Reduction Rod Connector
• 03663136005850: Ti 6.5mm x 40mm Left Rod Connector
• 03663136005591: Ti 6.0 mm x 80 mm Hex rod
• 03663136005539: Ti 6.0 mm x 60 mm Hex rod
• 03663136005218: Ti 6.5 mm Connector
• 03663136027395: MAT FOR REDUCTION CONTAINER
• 03663136027388: LID FOR REDUCTION CONTAINER
• 03663136027371: BASE FOR REDUCTION CONTAINER
• 03663136027364: Inferior UniThread Insert