InFill Lordotic ACF

GUDID 00814729025523

PINNACLE SPINE GROUP, LLC

Interspinous spinal fixation implant

• Primary Device ID: 00814729025523
• NIH Device Record Key: b6baba32-a78c-47e1-905d-cf1bf97adc1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InFill Lordotic ACF
• Version Model Number: 34-06-141209
• 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	00814729025523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140066

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00814729025523]

Radiation Sterilization;Moist Heat or Steam Sterilization

[00814729025523]

Radiation Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-08-26

On-Brand Devices [InFill Lordotic ACF]

• 00814729025592: 34-06-171310
• 00814729025585: 34-06-171309
• 00814729025578: 34-06-171308
• 00814729025561: 34-06-171307
• 00814729025554: 34-06-171306
• 00814729025547: 34-06-171305
• 00814729025530: 34-06-141210
• 00814729025523: 34-06-141209
• 00814729025516: 34-06-141208
• 00814729025509: 34-06-141207
• 00814729025493: 34-06-141206
• 00814729025486: 34-06-141205