ASTER

GUDID 08800071055440

OSTEONIC CO.,Ltd.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08800071055440
• NIH Device Record Key: 24df5953-3e0a-421d-846c-ca8f489bbbda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTER
• Version Model Number: N3A.20170
• Company DUNS: 688999370
• Company Name: OSTEONIC CO.,Ltd.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800071055440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K254182

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

[08800071055440]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-27
• Device Publish Date: 2026-03-19

Devices Manufactured by OSTEONIC CO.,Ltd.

• 08800071055440 - ASTER: 2026-03-27
• 08800071055440 - ASTER: 2026-03-27
• 08800071001539 - Signex: 2025-07-09
• 08800071001546 - Signex: 2025-07-09
• 08800071001553 - Signex: 2025-07-09
• 08800071004295 - Signex: 2025-07-09
• 08800071004301 - Signex: 2025-07-09
• 08800071022473 - Signex: 2025-07-09
• 08800071022480 - Signex: 2025-07-09