InFill 5-1 ALIF

GUDID 00814729025769

PINNACLE SPINE GROUP, LLC

Interspinous spinal fixation implant Interspinous spinal fixation implant

• Primary Device ID: 00814729025769
• NIH Device Record Key: 4ca52679-4922-40d6-88ab-f6786c49b9cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InFill 5-1 ALIF
• Version Model Number: 60-09-322612
• 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	00814729025769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133721

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00814729025769]

Radiation Sterilization;Moist Heat or Steam Sterilization

[00814729025769]

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 5-1 ALIF]

• 00814729026148: 60-12-392818
• 00814729026131: 60-12-392816
• 00814729026124: 60-09-392816
• 00814729026117: 60-12-392814
• 00814729026100: 60-09-392814
• 00814729026094: 60-12-392812
• 00814729026087: 60-09-392812
• 00814729026070: 60-12-392810
• 00814729026063: 60-09-392810
• 00814729026056: 60-12-392808
• 00814729026049: 60-09-392808
• 00814729026032: 60-12-362818
• 00814729026025: 60-12-362816
• 00814729026018: 60-09-362816
• 00814729026001: 60-12-362814
• 00814729025998: 60-09-362814
• 00814729025981: 60-12-362812
• 00814729025974: 60-09-362812
• 00814729025967: 60-12-362810
• 00814729025950: 60-09-362810
• 00814729025943: 60-12-362808
• 00814729025936: 60-09-362808
• 00814729025929: 60-12-362518
• 00814729025912: 60-12-362516
• 00814729025905: 60-09-362516
• 00814729025899: 60-12-362514
• 00814729025882: 60-09-362514
• 00814729025875: 60-12-362512
• 00814729025868: 60-09-362512
• 00814729025851: 60-12-362510
• 00814729025844: 60-09-362510
• 00814729025837: 60-12-362508
• 00814729025820: 60-09-362508
• 00814729025813: 60-12-322616
• 00814729025806: 60-09-322616
• 00814729025790: 60-12-322614
• 00814729025783: 60-09-322614
• 00814729025776: 60-12-322612
• 00814729025769: 60-09-322612
• 00814729025752: 60-12-322610
• 00814729025745: 60-09-322610
• 00814729025738: 60-12-322608
• 00814729025721: 60-09-322608