AIS-C II ACC104

GUDID M719ACC1040

AIS-C II Gun Inserter

Genesys Orthopedics Systems LLC

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: M719ACC1040
• NIH Device Record Key: ce02f9da-3f97-41d5-b832-77c4e8c73896
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIS-C II
• Version Model Number: 1
• Catalog Number: ACC104
• 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: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719ACC1040 [Primary]

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

[M719ACC1040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-12
• Device Publish Date: 2024-03-04

On-Brand Devices [AIS-C II]

• M719ACC1060: AIS-C II Impaction Inserter, Threaded
• M719ACC1050: AIS-C II Impaction Inserter
• M719ACC1040: AIS-C II Gun Inserter
• M719ACC1030: AIS-C II Anchor Extractor