Genesys Spine Apache® Interbody Fusion System GPH1418-M

GUDID M719GPH1418M0

14mm x 18 DEG Hyperlordotic Medium ALIF Trial

Genesys Orthopedics Systems LLC

Spinal implant trial

• Primary Device ID: M719GPH1418M0
• NIH Device Record Key: 8aa3d765-7047-4802-bed9-c8bec34b39b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesys Spine Apache® Interbody Fusion System
• Version Model Number: 1
• Catalog Number: GPH1418-M
• 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 Dimensions

• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter
• Angle: 18 degree
• Width: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GPH1418M0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153123

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

[M719GPH1418M0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-07-24

On-Brand Devices [Genesys Spine Apache® Interbody Fusion System]

• M719GPH1418M0: 14mm x 18 DEG Hyperlordotic Medium ALIF Trial
• M719GP734150: 15mm X 34mm 3DP Parallel TPLIF Ingot Trial
• M719GP734140: 14mm X 34mm 3DP Parallel TPLIF Ingot Trial
• M719GP734130: 13mm X 34mm 3DP Parallel TPLIF Ingot Trial
• M719GP734120: 12mm X 34mm 3DP Parallel TPLIF Ingot Trial
• M719GP734110: 11mm X 34mm 3DP Parallel TPLIF Ingot Trial
• M719GP734100: 10mm X 34mm 3DP Parallel TPLIF Ingot Trial
• M719GP734090: 9mm X 34mm 3DP Parallel TPLIF Ingot Trial
• M719GP734080: 8mm X 34mm 3DP Parallel TPLIF Ingot Trial
• M719GP734070: 7mm X 34mm 3DP Parallel TPLIF Ingot Trial
• M719GP732150: 15mm X 32mm 3DP Parallel TPLIF Ingot Trial
• M719GP732140: 14mm X 32mm 3DP Parallel TPLIF Ingot Trial
• M719GP732130: 13mm X 32mm 3DP Parallel TPLIF Ingot Trial
• M719GP732120: 12mm X 32mm 3DP Parallel TPLIF Ingot Trial
• M719GP732110: 11mm X 32mm 3DP Parallel TPLIF Ingot Trial
• M719GP732100: 10mm X 32mm 3DP Parallel TPLIF Ingot Trial
• M719GP732090: 9mm X 32mm 3DP Parallel TPLIF Ingot Trial
• M719GP732080: 8mm X 32mm 3DP Parallel TPLIF Ingot Trial
• M719GP732070: 7mm X 32mm 3DP Parallel TPLIF Ingot Trial
• M719GP7050: Small Silicone Handle
• M719GP631140: Cervical Star Trial - 14mm
• M719GP631120: Cervical Star Trial - 12mm
• M719GP630140: Cervical Star Rasp - 14mm
• M719GP630120: Cervical Star Rasp - 12mm
• M719GP53860: 12in 6mm 40° Fwd Anterior Kerrison Rongeur
• M719GP53840: 12in 4mm 40° Fwd Anterior Kerrison Rongeur
• M719GP5370: ALIF Rasp
• M719GP53260: 12in Pituitary Rongeur - 6mm Bite
• M719GP5140: 4mm Straight Pituitary Rongeur
• M719G30170: ALIF Accessory Caddy Lid
• M719G30160: ALIF Accessory Caddy
• M719G30150: Hyperlordotic ALIF Caddy Lid
• M719G30140: Hyperlordotic ALIF Caddy