AERIAL

GUDID 00889095717075

Torque Limiting Implant Driver, 2.0 Nm

GLOBUS MEDICAL, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00889095717075
• NIH Device Record Key: 7aaa9ff8-4e7b-4d60-9422-d2e713c3b687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AERIAL
• Version Model Number: 6117.0003
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• 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: +1(610)930-1800
• Email: info@globusmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095717075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180817

FDA Product Code

• PEK: Spinous process plate

Sterilization

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

[00889095717075]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-05
• Device Publish Date: 2019-06-27

On-Brand Devices [AERIAL]

• 00889095717112: Final Tightening Driver, Long
• 00889095717105: Final Tightening Driver, Short
• 00889095717082: Inserter Fork
• 00889095717075: Torque Limiting Implant Driver, 2.0 Nm
• 00889095717068: Inserter Tube
• 00889095717051: AERIAL Implant 12x22mm, 9-15mm
• 00889095717044: AERIAL Implant 12x22mm, 11-17mm, 15°
• 00889095717037: AERIAL Implant 12x22mm, 9-15mm, 15°
• 00889095717020: AERIAL Implant 12x22mm, 8-14mm, 10°
• 00889095717013: AERIAL Implant 12x22mm, 11-17mm
• 00889095717006: AERIAL Implant 12x22mm, 7mm-13mm
• 00889095716993: AERIAL Implant 10x22mm, 9-15mm
• 00889095716986: AERIAL Implant 10x22mm, 11-17mm, 15°
• 00889095716979: AERIAL Implant 10x22mm, 9-15mm, 15°
• 00889095716962: AERIAL Implant 10x22mm, 8-14mm, 10°
• 00889095716955: AERIAL Implant 10x22mm, 11-17mm
• 00889095716948: AERIAL Implant 10x22mm, 7mm-13mm
• 00889095716931: AERIAL Implant 8x22mm, 9-15mm
• 00889095716924: AERIAL Implant 8x22mm, 11-17mm, 15°
• 00889095716917: AERIAL Implant 8x22mm, 9-15mm, 15°
• 00889095716900: AERIAL Implant 8x22mm, 8-14mm, 10°
• 00889095716894: AERIAL Implant 8x22mm, 11-17mm
• 00889095716887: AERIAL Implant 8x22mm, 7mm-13mm