Indy

GUDID 00843210172224

Trials, 38x27, 16°, 15mm

Altus Spine, LLC

Spinal implant trial

• Primary Device ID: 00843210172224
• NIH Device Record Key: 1311090d-b783-4e58-8966-f851b1419b5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indy
• Version Model Number: 1030-38271615
• Company DUNS: 078331322
• Company Name: Altus Spine, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843210172224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182406

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

[00843210172224]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-19
• Device Publish Date: 2024-08-09

On-Brand Devices [Indy ]

• 00843210147338: T10 Screwdriver, AO Male Connection
• 00843210147321: T15 Self-Retaining Screwdriver
• 00843210147314: Ø4.2mm Tap
• 00843210147284: Inserter DTS Guide, 20mm H
• 00843210147277: Inserter DTS Guide, 19mm H
• 00843210147260: Inserter DTS Guide, 18mm H
• 00843210147253: Inserter DTS Guide, 17mm H
• 00843210147246: Inserter DTS Guide, 16mm H
• 00843210147239: Inserter DTS Guide, 15mm H
• 00843210147222: Inserter DTS Guide, 14mm H
• 00843210147215: Inserter DTS Guide, 13mm H
• 00843210147208: Inserter DTS Guide, 12mm H
• 00843210147192: Inserter DTS Guide, 11mm H
• 00843210147185: Inserter Guide
• 00843210147178: Implant Inserter
• 00843210147048: U-Joint 4.2mm Tap
• 00843210143866: Tamp, Indy ALIF
• 00843210143828: Graft Packing Block Indy ALIF
• 00843210143583: 19mm H, 12° Distractor
• 00843210143576: 17mm H, 12° Distractor
• 00843210143569: 15mm H, 12° Distractor
• 00843210143552: 13mm H, 12° Distractor
• 00843210143545: 9mm H, 12° Distractor
• 00843210143538: 42mm x 30mm, 25°, 19mm Trial
• 00843210143521: 42mm x 30mm, 25°, 17mm Trial
• 00843210143514: 42mm x 30mm, 20°, 19mm Trial
• 00843210143507: 42mm x 30mm, 20°, 17mm Trial
• 00843210143491: 42mm x 30mm, 20°, 15mm Trial
• 00843210143484: 42mm x 30mm, 16°, 19mm Trial
• 00843210143477: 42mm x 30mm, 16°, 17mm Trial
• 00843210143460: 42mm x 30mm, 16°, 15mm Trial
• 00843210143453: 42mm x 30mm, 16°, 13mm Trial
• 00843210143446: 42mm x 30mm, 12°, 19mm Trial
• 00843210143439: 42mm x 30mm, 12°, 17mm Trial
• 00843210143422: 42mm x 30mm, 12°, 15mm Trial
• 00843210143415: 42mm x 30mm, 12°, 13mm Trial
• 00843210143408: 42mm x 30mm, 12°, 11mm Trial
• 00843210143392: 42mm x 30mm, 8°, 19mm Trial
• 00843210143385: 42mm x 30mm, 8°, 17mm Trial
• 00843210143378: 42mm x 30mm, 8°, 15mm Trial
• 00843210143361: 42mm x 30mm, 8°, 13mm Trial
• 00843210143354: 42mm x 30mm, 8°, 11mm Trial
• 00843210143347: 38mm x 27mm, 25°, 19mm Trial
• 00843210142715: 32mm x 24mm, 8°, 19mm Trial
• 00843210142708: 32mm x 24mm, 8°, 17mm Trial
• 00843210139029: 32mm x 24mm, 8°, 12mm Ti Spacer - Brickyard ALIF System
• 00843210139012: 32mm x 24mm, 8°, 10mm Ti Spacer - Brickyard ALIF System
• 00843210138473: 32mm x 24mm, 16°, 11mm Ti Spacer
• 00843210138466: 32mm x 24mm, 12°, 19mm Ti Spacer
• 00843210138459: 32mm x 24mm, 12°, 17mm Ti Spacer