ANAX™ 5.5 CT SPINAL SYSTEM

GUDID 08800015999014

Innosys Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800015999014
• NIH Device Record Key: 6e2c934c-66eb-440f-ab37-64cd08f919db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANAX™ 5.5 CT SPINAL SYSTEM
• Version Model Number: CTC5535
• 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	08800015999014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181824

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

Moist Heat or Steam Sterilization

[08800015999014]

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: 2019-07-31

On-Brand Devices [ANAX™ 5.5 CT SPINAL SYSTEM]

• 08800037544957: CT0090
• 08800037544933: CT0180
• 08800037544926: CT0131
• 08800037509468: CTA1100
• 08800037509420: CT0130
• 08800037509413: CT0075
• 08800037509406: CT0060
• 08800037500663: CT0110
• 08800037500649: CT0090
• 08800015999946: CT0080
• 08800015999922: CT0065
• 08800015999915: CT0055
• 08800015999908: CT0050
• 08800015999892: CT0045
• 08800015999885: CT0031
• 08800015999878: CT0030
• 08800015999854: CT0010
• 08800015999786: CTC7660
• 08800015999779: CTC7655
• 08800015999762: CTC7650
• 08800015999755: CTC7645
• 08800015999748: CTC7640
• 08800015999731: CTC7635
• 08800015999724: CTC7630
• 08800015999717: CTC7625
• 08800015999700: CTC7560
• 08800015999694: CTC7555
• 08800015999687: CTC7550
• 08800015999670: CTC7545
• 08800015999663: CTC7540
• 08800015999656: CTC7535
• 08800015999649: CTC7530
• 08800015999632: CTC7525
• 08800015999625: CTC7160
• 08800015999618: CTC7155
• 08800015999601: CTC7150
• 08800015999595: CTC7145
• 08800015999588: CTC7140
• 08800015999571: CTC7135
• 08800015999564: CTC7130
• 08800015999557: CTC7125
• 08800015999540: CTC7060
• 08800015999533: CTC7055
• 08800015999526: CTC7050
• 08800015999519: CTC7045
• 08800015999502: CTC7040
• 08800015999496: CTC7035
• 08800015999489: CTC7030
• 08800015999472: CTC7025
• 08800015999465: CTC6660