3DP AIS-C II Cervical Interbody System ACC804-09L

GUDID M719ACC80409L0

9 mm AIS-C II Cervical-SA, Large, 3DP 7° Lordotic Interbody

Genesys Orthopedics Systems LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M719ACC80409L0
• NIH Device Record Key: 3846d0df-e17c-4ca2-ab68-443d2c045ad8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3DP AIS-C II Cervical Interbody System
• Version Model Number: 1
• Catalog Number: ACC804-09L
• 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: true
• 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 Dimensions

• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719ACC80409L0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191489

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

Moist Heat or Steam Sterilization

[M719ACC80409L0]

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 [3DP AIS-C II Cervical Interbody System]

• M719SEC80712L0: Stryker 12 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
• M719SEC80711S0: Stryker 11 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody
• M719SEC80711L0: Stryker 11 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
• M719SEC80710S0: Stryker 10 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody
• M719SEC80710L0: Stryker 10 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
• M719SEC80709S0: Stryker 9 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody
• M719SEC80709L0: Stryker 9 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
• M719SEC80708S0: Stryker 8 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody
• M719SEC80708L0: Stryker 8 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
• M719SEC80707S0: Stryker 7 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody
• M719SEC80707L0: Stryker 7 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
• M719SEC80706S0: Stryker 6 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody
• M719SEC80706L0: Stryker 6 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody
• M719SEC80612S0: Stryker 12 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
• M719SEC80612L0: Stryker 12 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
• M719SEC80611S0: Stryker 11 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
• M719SEC80611L0: Stryker 11 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
• M719SEC80610S0: Stryker 10 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
• M719SEC80610L0: Stryker 10 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
• M719SEC80609S0: Stryker 9 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
• M719SEC80609L0: Stryker 9 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
• M719SEC80608S0: Stryker 8 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
• M719SEC80608L0: Stryker 8 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
• M719SEC80607S0: Stryker 7 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
• M719SEC80607L0: Stryker 7 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
• M719SEC80606S0: Stryker 6 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
• M719SEC80606L0: Stryker 6 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
• M719SEC80605S0: Stryker 5 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody
• M719SEC80605L0: Stryker 5 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody
• M719SEC80512S0: Stryker 12 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
• M719SEC80512L0: Stryker 12 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
• M719SEC80511S0: Stryker 11 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
• M719SEC80511L0: Stryker 11 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
• M719SEC80510S0: Stryker 10 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
• M719SEC80510L0: Stryker 10 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
• M719SEC80509S0: Stryker 9 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
• M719SEC80509L0: Stryker 9 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
• M719SEC80508S0: Stryker 8 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
• M719SEC80508L0: Stryker 8 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
• M719SEC80507S0: Stryker 7 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
• M719SEC80507L0: Stryker 7 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
• M719SEC80506S0: Stryker 6 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
• M719SEC80506L0: Stryker 6 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
• M719SEC80505S0: Stryker 5 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody
• M719SEC80505L0: Stryker 5 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody
• M719SEC80412S0: Stryker 12 mm AIS-C II Cervical-SA, Small, 3DP 7° Lordotic Interbody
• M719SEC80412L0: Stryker 12 mm AIS-C II Cervical-SA, Large, 3DP 7° Lordotic Interbody
• M719SEC80411S0: Stryker 11 mm AIS-C II Cervical-SA, Small, 3DP 7° Lordotic Interbody
• M719SEC80411L0: Stryker 11 mm AIS-C II Cervical-SA, Large, 3DP 7° Lordotic Interbody
• M719SEC80410S0: Stryker 10 mm AIS-C II Cervical-SA, Small, 3DP 7° Lordotic Interbody