Apache Anchored Cervical Interbody Fusion System GCV109-05-L

GUDID M719GCV10905L0

5mm Large Cervical Trial

Genesys Orthopedics Systems LLC

Spinal implant trial

• Primary Device ID: M719GCV10905L0
• NIH Device Record Key: 7bcd5b88-5e20-4d08-a035-861aa47a2749
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apache Anchored Cervical Interbody Fusion System
• Version Model Number: 1
• Catalog Number: GCV109-05-L
• 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
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GCV10905L0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152099

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

[M719GCV10905L0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-28
• Device Publish Date: 2023-07-20

On-Brand Devices [Apache Anchored Cervical Interbody Fusion System]

• M719GCV10905L0: 5mm Large Cervical Trial
• M719GCV10811L0: Large 11mm Cervical Rasp