Altus Spine Interbody Fusion System

GUDID 00843210130330

Implant Inserter, Bent

Altus Spine, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: 00843210130330
• NIH Device Record Key: 6db235eb-51ae-4e25-9fd2-270f43c14123
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Altus Spine Interbody Fusion System
• Version Model Number: 1000-0300SB
• 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: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843210130330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170553

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

[00843210130330]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-09-25

On-Brand Devices [Altus Spine Interbody Fusion System]

• 00843210131894: Trial
• 00843210131887: Trial
• 00843210131870: Trial
• 00843210131863: Trial
• 00843210131856: Trial
• 00843210131849: Trial
• 00843210131832: Trial
• 00843210131825: Trial
• 00843210131818: Trial
• 00843210131801: Trial
• 00843210131795: Trial
• 00843210131788: Implant Inserter
• 00843210131771: Inserter with Tabs
• 00843210131764: Implant Inserter
• 00843210131757: Trial
• 00843210131740: Trial
• 00843210131733: Trial
• 00843210131726: Trial
• 00843210131719: Trial
• 00843210131702: Trial
• 00843210131696: Trial
• 00843210131689: T-Handle Implant Inserter
• 00843210131672: Broach Trial
• 00843210131665: Broach Trial
• 00843210131658: Broach Trial
• 00843210131641: Broach Trial
• 00843210131634: Broach Trial
• 00843210131627: Broach Trial
• 00843210131610: Broach Trial
• 00843210131603: Broach Trial
• 00843210131597: Broach Trial
• 00843210131580: Broach Trial
• 00843210131573: Broach Trial
• 00843210131566: Broach Trial
• 00843210131559: Broach Trial
• 00843210131542: Trial Spacer
• 00843210131535: Trial Spacer
• 00843210131528: Trial Spacer
• 00843210131511: Trial Spacer
• 00843210131504: Trial Spacer
• 00843210131498: Trial Spacer
• 00843210131481: Trial Spacer
• 00843210131474: Trial Spacer
• 00843210131467: Trial Spacer
• 00843210131450: Trial Spacer
• 00843210131443: Trial Spacer
• 00843210131436: Trial Spacer
• 00843210131429: Trial Spacer
• 00843210130927: 26/30mm Paddle Sizer, Angled
• 00843210130910: 26/30mm Paddle Sizer, Angled