P.L.U.S.®

GUDID 03663136017884

ST 8.5 mm X 45 mm SCREW

SPINEVISION

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 03663136017884
• NIH Device Record Key: f7c9f2d3-9a7d-4362-9305-66c5b9e8f3b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.L.U.S.®
• Version Model Number: U1-S845
• 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	03663136017884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013312

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[03663136017884]

Moist Heat or Steam Sterilization

[03663136017884]

Moist Heat or Steam Sterilization

[03663136017884]

Moist Heat or Steam Sterilization

[03663136017884]

Moist Heat or Steam Sterilization

[03663136017884]

Moist Heat or Steam Sterilization

[03663136017884]

Moist Heat or Steam Sterilization

[03663136017884]

Moist Heat or Steam Sterilization

[03663136017884]

Moist Heat or Steam Sterilization

[03663136017884]

Moist Heat or Steam Sterilization

[03663136017884]

Moist Heat or Steam Sterilization

[03663136017884]

Moist Heat or Steam Sterilization

[03663136017884]

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: 2015-10-21

On-Brand Devices [P.L.U.S.®]

• 03663136018126: ST 65mm BAR FOR MATC
• 03663136018102: ST 59mm BAR FOR MATC
• 03663136018096: ST 56mm BAR FOR MATC
• 03663136018089: ST 53mm BAR FOR MATC
• 03663136018065: ST 47mm BAR FOR MATC
• 03663136018058: ST 44mm BAR FOR MATC
• 03663136018041: ST 41mm BAR FOR MATC
• 03663136018034: ST 38mm BAR FOR MATC
• 03663136018027: ST 35mm BAR FOR MATC
• 03663136018003: ST 29mm BAR FOR MATC
• 03663136017969: ST BAR FOR MATC / FTC
• 03663136017945: ST MULTI AXIAL TRANSVERSE CONNECTOR
• 03663136026114: Tray 6 for PLUS
• 03663136025742: ST HOOK SUPPORT
• 03663136025094: Universal Pedicle Screwdriver
• 03663136025087: Screwdriver for Multi-axial Screws
• 03663136025056: ILIO SACRAL 5 mm HEX CANNULATED SCREWDRIVER
• 03663136021683: ST 6.0 mm x 50 mm ROD
• 03663136021614: Ti 6.0 mm x 540 mm HEX ROD
• 03663136021539: Ti 6.0 mm x 450 mm HEX ROD
• 03663136020365: ST 6.0 mm x 260 mm HEX ROD
• 03663136017884: ST 8.5 mm X 45 mm SCREW
• 03663136017396: TI 5.5mm X 50mm SCREW
• 03663136015972: TI 8.5 mm X 35 mm MULTI-AXIAL SCREW
• 03663136014494: ST 7.5mm X 50mm ILIAC SCREW
• 03663136013626: Clip introducer long stroke
• 03663136013619: Clip guide long stroke