P.L.U.S.®

GUDID 03663136015231

Stainless Steel spherical locking screw (x2)

SPINEVISION

Spinal bone set screw

• Primary Device ID: 03663136015231
• NIH Device Record Key: 2e113838-2128-4544-bb3b-b822f7a4b085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.L.U.S.®
• Version Model Number: U1-L402
• 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

Customer Support Contacts

• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com

Device Dimensions

• Length: 35 Millimeter
• Width: 12 Millimeter
• Length: 35 Millimeter
• Width: 12 Millimeter
• Length: 35 Millimeter
• Width: 12 Millimeter
• Length: 35 Millimeter
• Width: 12 Millimeter
• Length: 35 Millimeter
• Width: 12 Millimeter
• Length: 35 Millimeter
• Width: 12 Millimeter
• Length: 35 Millimeter
• Width: 12 Millimeter
• Length: 35 Millimeter
• Width: 12 Millimeter
• Length: 35 Millimeter
• Width: 12 Millimeter
• Length: 35 Millimeter
• Width: 12 Millimeter
• Length: 35 Millimeter
• Width: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663136015231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032398

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[03663136015231]

Moist Heat or Steam Sterilization

[03663136015231]

Moist Heat or Steam Sterilization

[03663136015231]

Moist Heat or Steam Sterilization

[03663136015231]

Moist Heat or Steam Sterilization

[03663136015231]

Moist Heat or Steam Sterilization

[03663136015231]

Moist Heat or Steam Sterilization

[03663136015231]

Moist Heat or Steam Sterilization

[03663136015231]

Moist Heat or Steam Sterilization

[03663136015231]

Moist Heat or Steam Sterilization

[03663136015231]

Moist Heat or Steam Sterilization

[03663136015231]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-12-16
• Device Publish Date: 2019-02-12

On-Brand Devices [ P.L.U.S.®]

• 03663136015248: Spherical locking screw (x2)
• 03663136015231: Stainless Steel spherical locking screw (x2)