VEGA

GUDID 08800071020912

OSTEONIC CO.,Ltd.

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 08800071020912
• NIH Device Record Key: 6dfed9b3-80c5-4a90-be00-fc78e00ef363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VEGA
• Version Model Number: CIS1023-BC
• 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	08800071020912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210122

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-17
• Device Publish Date: 2023-02-09

On-Brand Devices [VEGA ]

• 08800071020929: CIS1028-BC
• 08800071020912: CIS1023-BC
• 08800071020905: CIS0928-BC
• 08800071020899: CIS0923-BC
• 08800071020882: CIS0828-BC
• 08800071020875: CIS0823-BC
• 08800071020868: CIS1030-BC
• 08800071020851: CIS1025-BC
• 08800071020844: CIS0930-BC
• 08800071020837: CIS0925-BC
• 08800071020820: CIS0830-BC
• 08800071020813: CIS0825-BC
• 08800071020806: CIS0730-BC
• 08800071020790: CIS0725-BC