ANAX™ 5.8 SPINAL SYSTEM

GUDID 08800015996884

Innosys Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800015996884
• NIH Device Record Key: e4f60c2c-721f-4ebd-aea8-fa96d3287ad8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANAX™ 5.8 SPINAL SYSTEM
• Version Model Number: SFTA1450
• Company DUNS: 688811082
• Company Name: Innosys Co., Ltd.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800015996884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132101

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

[08800015996884]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-19
• Device Publish Date: 2018-11-12

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