Spinal Elements

GUDID 00190776406080

Triangle Shaver, 35°

Avalign Technologies, Inc.

Orthopaedic osteotome

• Primary Device ID: 00190776406080
• NIH Device Record Key: b7fd676c-057a-4769-aa6a-7949855addb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spinal Elements
• Version Model Number: 69103-035
• Company DUNS: 792528510
• Company Name: Avalign Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com
• Phone: +18772891096
• Email: product.questions@avalign.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190776406080 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

[00190776406080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-31
• Device Publish Date: 2025-03-21

On-Brand Devices [Spinal Elements]

• 00190776406165: Posterior Vertebral Body Punch, 8mm x 25mm
• 00190776406158: Posterior Vertebral Body Punch, 5mm x 25mm
• 00190776406141: Posterior Vertebral Body Punch, 5mm x 20mm
• 00190776406134: Right Angle Vertebral Body Osteotome, 7mm x 7mm
• 00190776406127: Posterior Wall Kerrison, 5mm x 20mm
• 00190776406110: Angular Template, 35°
• 00190776406103: Angular Template, 30°
• 00190776406097: Angular Template, 25°
• 00190776406080: Triangle Shaver, 35°
• 00190776406073: Triangle Shaver, 30°
• 00190776406066: Triangle Shaver, 25°
• 00190776406059: Straight Osteotome, 13mm
• 00190776406042: Straight Osteotome, 10mm
• 00190776406035: Straight Osteotome, 6mm
• 00190776406028: Adjustable Vertebral Body Retractor, 30mm
• 00190776406011: Adjustable Vertebral Body Retractor, 20mm
• 00190776406004: Adjustable Vertebral Body Retractor, 15mm
• 00190776405991: Spinal Elements Osteotomy Instruments Tray