UNI-THREAD™

GUDID 03663136032641

Rigid rod 6.0 mm x 110 mm

SPINEVISION

Bone-screw internal spinal fixation system rod

• Primary Device ID: 03663136032641
• NIH Device Record Key: 5465e9a9-d9dc-49de-b39c-69ebb5a61c8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNI-THREAD™
• Version Model Number: L2-R611HT
• 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

Device Dimensions

• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663136032641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052406

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[03663136032641]

Moist Heat or Steam Sterilization

[03663136032641]

Moist Heat or Steam Sterilization

[03663136032641]

Moist Heat or Steam Sterilization

[03663136032641]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-12-19
• Device Publish Date: 2018-09-04

On-Brand Devices [UNI-THREAD™]

• 03663136032658: Rigid rod 6.0 mm x 130 mm
• 03663136032641: Rigid rod 6.0 mm x 110 mm