InFill Graft Delivery System (Modified)

GUDID 00814729026162

PINNACLE SPINE GROUP, LLC

Orthopaedic cement dispenser

• Primary Device ID: 00814729026162
• NIH Device Record Key: d4e5c413-3284-4580-ab9e-618dc9e1e8e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InFill Graft Delivery System (Modified)
• Version Model Number: 99-0520
• Company DUNS: 962347980
• Company Name: PINNACLE SPINE GROUP, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814729026162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121476

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

[00814729026162]

Radiation Sterilization;Moist Heat or Steam Sterilization

[00814729026162]

Radiation Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-26

Devices Manufactured by PINNACLE SPINE GROUP, LLC

• 00814729020009 - InFill V2 Lateral PE: 2019-04-23
• 00814729020016 - InFill V2 Lateral PE: 2019-04-23
• 00814729020023 - InFill V2 Lateral PE: 2019-04-23
• 00814729020030 - InFill V2 Lateral PE: 2019-04-23
• 00814729020047 - InFill V2 Lateral PE: 2019-04-23
• 00814729020054 - InFill V2 Lateral PE: 2019-04-23
• 00814729020061 - InFill V2 Lateral PE: 2019-04-23
• 00814729020078 - InFill V2 Lateral PE: 2019-04-23