Stasys-C Standalone 3DP ACC202-1

GUDID M719ACC20210

1mm Stasys Cervical Standalone Inserter Tip

Genesys Orthopedics Systems LLC

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: M719ACC20210
• NIH Device Record Key: 7666e776-164f-4baa-981f-5956f861ff7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stasys-C Standalone 3DP
• Version Model Number: 1
• Catalog Number: ACC202-1
• 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: true
• 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
• Phone: 5123817089
• Email: info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719ACC20210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233594

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

[M719ACC20210]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-08
• Device Publish Date: 2025-08-30

On-Brand Devices [Stasys-C Standalone 3DP ]

• M719ACC2060: Stasys Cervical Standalone Impaction Inserter, Threaded
• M719ACC2050: Stasys Cervical Standalone Impaction Inserter
• M719ACC2040: Stasys Cervical Standalone Gun Inserter
• M719ACC202N0: No Stop Stasys Cervical Standalone Inserter Tip
• M719ACC20240: 4mm Stasys Cervical Standalone Inserter Tip
• M719ACC20230: 3mm Stasys Cervical Standalone Inserter Tip
• M719ACC20220: 2mm Stasys Cervical Standalone Inserter Tip
• M719ACC20210: 1mm Stasys Cervical Standalone Inserter Tip
• M719ACC20200: 0mm Stasys Cervical Standalone Inserter Tip
• M719ACC1110: Stasys Cervical Standalone Anchor Extraction Screw