AIS-C Standalone System GAC100-XSWX

GUDID M719GAC100XSWX0

GAC100 Inserter with Welded Tip

Genesys Orthopedics Systems LLC

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: M719GAC100XSWX0
• NIH Device Record Key: 6640cbb8-5839-4aea-8a89-dbfbbb8f71fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIS-C Standalone System
• Version Model Number: 1
• Catalog Number: GAC100-XSWX
• 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
• Phone: 5123817089
• Email: info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GAC100XSWX0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181295

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

Moist Heat or Steam Sterilization

[M719GAC100XSWX0]

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 [AIS-C Standalone System]

• M719GAC100XSWX0: GAC100 Inserter with Welded Tip
• M719GAC12LP0: 12mm AIS-C CERVICAL STANDALONE, LARGE, PARALLEL
• M719GAC11SP0: 11mm AIS-C CERVICAL STANDALONE, SMALL, PARALLEL
• M719GAC11LP0: 11mm AIS-C CERVICAL STANDALONE, LARGE, PARALLEL
• M719GAC10SP0: 10mm AIS-C CERVICAL STANDALONE, SMALL, PARALLEL
• M719GAC10LP0: 10mm AIS-C CERVICAL STANDALONE, LARGE, PARALLEL
• M719GAC09SP0: 9mm AIS-C CERVICAL STANDALONE, SMALL, PARALLEL
• M719GAC09LP0: 9mm AIS-C CERVICAL STANDALONE, LARGE, PARALLEL
• M719GAC08SP0: 8mm AIS-C CERVICAL STANDALONE, SMALL, PARALLEL
• M719GAC08LP0: 8mm AIS-C CERVICAL STANDALONE, LARGE, PARALLEL
• M719GAC07SP0: 7mm AIS-C CERVICAL STANDALONE, SMALL, PARALLEL
• M719GAC07LP0: 7mm AIS-C CERVICAL STANDALONE, LARGE, PARALLEL
• M719GAC06SP0: 5mm AIS-C CERVICAL STANDALONE, SMALL, PARALLEL
• M719GAC06LP0: 6mm AIS-C CERVICAL STANDALONE, LARGE, PARALLEL
• M719GAC05SP0: 5mm AIS-C CERVICAL STANDALONE, SMALL, PARALLEL
• M719GAC05LP0: 5mm AIS-C CERVICAL STANDALONE, LARGE, PARALLEL