Suzuka Interbody Fusion System

GUDID 00843210119694

Interbody Fusion Device, PEEK

Altus Spine, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: 00843210119694
• NIH Device Record Key: b5f1cd35-0f20-4f65-b885-65a8b377bba6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suzuka Interbody Fusion System
• Version Model Number: S420509
• 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: true
• 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

Device Dimensions

• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843210119694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172253

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00843210119694]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-12-28

On-Brand Devices [Suzuka Interbody Fusion System]

• 00843210133379: Suzuka Sterilization Case
• 00843210133362: ALR Tamp
• 00843210133355: Suzuka Module Lid
• 00843210133348: 14mm/17mm 5 deg ALR Implant Module Lid
• 00843210133331: 14mm/17mm 5 deg ALR Implant Module
• 00843210133324: Suzuka Implant Module Assy 14 x 12.5
• 00843210121383: Interbody Fusion Device, PEEK ALR
• 00843210121376: Interbody Fusion Device, PEEK ALR
• 00843210121369: Interbody Fusion Device, PEEK ALR
• 00843210121352: Interbody Fusion Device, PEEK ALR
• 00843210121345: Interbody Fusion Device, PEEK ALR
• 00843210121338: Interbody Fusion Device, PEEK ALR
• 00843210121321: Interbody Fusion Device, PEEK ALR
• 00843210121314: Interbody Fusion Device, PEEK ALR
• 00843210121307: Interbody Fusion Device, PEEK ALR
• 00843210121291: Interbody Fusion Device, PEEK ALR
• 00843210121284: Interbody Fusion Device, PEEK ALR
• 00843210121277: Interbody Fusion Device, PEEK ALR
• 00843210121260: Interbody Fusion Device, PEEK ALR
• 00843210121253: Interbody Fusion Device, PEEK ALR
• 00843210121246: Interbody Fusion Device, PEEK ALR
• 00843210121239: Interbody Fusion Device, PEEK ALR
• 00843210121222: Interbody Fusion Device, PEEK ALR
• 00843210121215: Interbody Fusion Device, PEEK ALR
• 00843210121208: Interbody Fusion Device, PEEK ALR
• 00843210121192: Interbody Fusion Device, PEEK ALR
• 00843210121185: Interbody Fusion Device, PEEK ALR
• 00843210121178: Interbody Fusion Device, PEEK ALR
• 00843210121161: Interbody Fusion Device, PEEK ALR
• 00843210121154: Interbody Fusion Device, PEEK ALR
• 00843210121147: Interbody Fusion Device, PEEK ALR
• 00843210121130: Interbody Fusion Device, PEEK ALR
• 00843210121123: Interbody Fusion Device, PEEK ALR
• 00843210121116: Interbody Fusion Device, PEEK ALR
• 00843210121109: Interbody Fusion Device, PEEK ALR
• 00843210121093: Interbody Fusion Device, PEEK ALR
• 00843210121086: Interbody Fusion Device, PEEK ALR
• 00843210121079: Interbody Fusion Device, PEEK ALR
• 00843210121062: Interbody Fusion Device, PEEK ALR
• 00843210121055: Interbody Fusion Device, PEEK ALR
• 00843210121048: Interbody Fusion Device, PEEK ALR
• 00843210121031: Interbody Fusion Device, PEEK ALR
• 00843210121024: Interbody Fusion Device, PEEK ALR
• 00843210121017: Interbody Fusion Device, PEEK ALR
• 00843210121000: Interbody Fusion Device, PEEK ALR
• 00843210120997: Interbody Fusion Device, PEEK ALR
• 00843210120980: Interbody Fusion Device, PEEK ALR
• 00843210120973: Interbody Fusion Device, PEEK ALR
• 00843210120966: Interbody Fusion Device, PEEK ALR
• 00843210120959: Interbody Fusion Device, PEEK ALR