Stasys-C Standalone PEEK ACC108

GUDID M719ACC1080

AIS-C II Cage Only Inserter

Genesys Orthopedics Systems LLC

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: M719ACC1080
• NIH Device Record Key: 99265996-7ddc-458c-833f-30e93412bddb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stasys-C Standalone PEEK
• Version Model Number: 1
• Catalog Number: ACC108
• Company DUNS: 017921066
• Company Name: Genesys Orthopedics Systems LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com
• Phone: 5123817089
• Email: info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719ACC1080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242483

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[M719ACC1080]

Moist Heat or Steam Sterilization

[M719ACC1080]

Moist Heat or Steam Sterilization

[M719ACC1080]

Moist Heat or Steam Sterilization

[M719ACC1080]

Moist Heat or Steam Sterilization

[M719ACC1080]

Moist Heat or Steam Sterilization

[M719ACC1080]

Moist Heat or Steam Sterilization

[M719ACC1080]

Moist Heat or Steam Sterilization

[M719ACC1080]

Moist Heat or Steam Sterilization

[M719ACC1080]

Moist Heat or Steam Sterilization

[M719ACC1080]

Moist Heat or Steam Sterilization

[M719ACC1080]

Moist Heat or Steam Sterilization

[M719ACC1080]

Moist Heat or Steam Sterilization

[M719ACC1080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-23
• Device Publish Date: 2025-07-15

On-Brand Devices [Stasys-C Standalone PEEK]

• M719ACC830XXL0: AIS-C II Cervical SA Anchor - Extra Extra Large
• M719ACC830XL0: AIS-C II Cervical SA Anchor - Extra Large
• M719ACC830SM0: AIS-C II Cervical SA Anchor - Small
• M719ACC830MD0: AIS-C II Cervical SA Anchor - Medium
• M719ACC830LG0: AIS-C II Cervical SA Anchors - Large
• M719ACC1090: AIS-C II Anchor Finisher Punch
• M719ACC1080: AIS-C II Cage Only Inserter
• M719ACC1070: AIS-C II Anchor Finisher