ANAX™ 5.5 SPINAL SYSTEM

GUDID 08800037520494

Innosys Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800037520494
• NIH Device Record Key: ace9a586-d1c4-418a-9907-b99bd3eadd8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANAX™ 5.5 SPINAL SYSTEM
• Version Model Number: SFDA6560LR
• 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	08800037520494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173524

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

[08800037520494]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-19
• Device Publish Date: 2019-10-09

On-Brand Devices [ANAX™ 5.5 SPINAL SYSTEM]

• 08800037544919: SF0360
• 08800037544902: SF0350
• 08800037520968: SFM0220
• 08800037520920: SFDA8095LR
• 08800037520913: SFDA8090LR
• 08800037520906: SFDA8085LR
• 08800037520890: SFDA8080LR
• 08800037520883: SFDA8075LR
• 08800037520876: SFDA8070LR
• 08800037520869: SFDA8065LR
• 08800037520852: SFDA8060LR
• 08800037520845: SFDA8055LR
• 08800037520838: SFDA8050LR
• 08800037520821: SFDA8045LR
• 08800037520814: SFDA8040LR
• 08800037520807: SFDA8035LR
• 08800037520791: SFDA8030LR
• 08800037520784: SFDA7595LR
• 08800037520777: SFDA7590LR
• 08800037520760: SFDA7585LR
• 08800037520753: SFDA7580LR
• 08800037520746: SFDA7575LR
• 08800037520739: SFDA7570LR
• 08800037520722: SFDA7565LR
• 08800037520715: SFDA7560LR
• 08800037520708: SFDA7555LR
• 08800037520692: SFDA7550LR
• 08800037520685: SFDA7545LR
• 08800037520678: SFDA7540LR
• 08800037520661: SFDA7535LR
• 08800037520654: SFDA7530LR
• 08800037520647: SFDA7080LR
• 08800037520630: SFDA7075LR
• 08800037520623: SFDA7070LR
• 08800037520616: SFDA7065LR
• 08800037520609: SFDA7060LR
• 08800037520593: SFDA7055LR
• 08800037520586: SFDA7050LR
• 08800037520579: SFDA7045LR
• 08800037520562: SFDA7040LR
• 08800037520555: SFDA7035LR
• 08800037520548: SFDA7030LR
• 08800037520531: SFDA6580LR
• 08800037520524: SFDA6575LR
• 08800037520517: SFDA6570LR
• 08800037520500: SFDA6565LR
• 08800037520494: SFDA6560LR
• 08800037520487: SFDA6555LR
• 08800037520470: SFDA6550LR
• 08800037520463: SFDA6545LR