Revolution 11645504

GUDID 00814033020115

4.5 X 50mm Bone Screw, 4mm Offset

INTELLIGENT IMPLANT SYSTEMS, LLC

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00814033020115
• NIH Device Record Key: 69711d1d-4595-418f-b4b8-f0f57b6e5f21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolution
• Version Model Number: 11645504
• Catalog Number: 11645504
• Company DUNS: 013742030
• Company Name: INTELLIGENT IMPLANT 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: true
• 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: 704-424-1009
• Email: info@intelligentimplantsystems.com
• Phone: 704-424-1009
• Email: info@intelligentimplantsystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814033020115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142939

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-14

On-Brand Devices [Revolution]

• 00814033020689: 25-30 mm Contoured Connector
• 00814033020672: 20-25 mm Contoured Connector
• 00814033020665: 15-20 mm Contoured Connector
• 00814033020627: 20-25mm Straight Connector
• 00814033020610: 15-20mm Straight Connector
• 00814033020320: 7.5 X 55mm Cannulated Bone Screw, 4mm Offset
• 00814033020313: 7.5 X 50mm Cannulated Bone Screw, 4mm Offset
• 00814033020306: 7.5 X 45mm Cannulated Bone Screw, 4mm Offset
• 00814033020290: 7.5 X 40mm Cannulated Bone Screw, 4mm Offset
• 00814033020283: 7.5 X 35mm Cannulated Bone Screw, 4mm Offset
• 00814033020276: 7.5 X 30mm Cannulated Bone Screw, 4mm Offset
• 00814033020269: 7.5 X 25mm Cannulated Bone Screw, 4mm Offset
• 00814033020252: 6.5 X55mm Cannulated Bone Screw, 4mm Offset
• 00814033020245: 6.5 X50mm Cannulated Bone Screw, 4mm Offset
• 00814033020238: 6.5 X45mm Cannulated Bone Screw, 4mm Offset
• 00814033020221: 6.5 X40mm Cannulated Bone Screw, 4mm Offset
• 00814033020214: 6.5 X 35mm Cannulated Bone Screw, 4mm Offset
• 00814033020207: 6.5 X 30mm Cannulated Bone Screw, 4mm Offset
• 00814033020191: 6.5 X 25mm Cannulated Bone Screw, 4mm Offset
• 00814033020184: 5.5 X 55mm Cannulated Bone Screw, 4mm Offset
• 00814033020177: 5.5 X 50mm Cannulated Bone Screw, 4mm Offset
• 00814033020160: 5.5 X 45mm Cannulated Bone Screw, 4mm Offset
• 00814033020153: 5.5 X 40mm Cannulated Bone Screw, 4mm Offset
• 00814033020146: 5.5 X 35mm Cannulated Bone Screw, 4mm Offset
• 00814033020139: 5.5 X 30mm Cannulated Bone Screw, 4mm Offset
• 00814033020122: 5.5 X 25mm Cannulated Bone Screw, 4mm Offset
• 00814033020115: 4.5 X 50mm Bone Screw, 4mm Offset
• 00814033020108: 4.5 X 45mm Bone Screw, 4mm Offset
• 00814033020092: 4.5 X 40mm Bone Screw, 4mm Offset
• 00814033020085: 4.5 X 35mm Bone Screw, 4mm Offset
• 00814033020078: 4.5 X 30mm Bone Screw, 4mm Offset
• 00814033020061: 4.5 X 25mm Bone Screw, 4mm Offset
• 00814033020054: 50-55mm Contoured Connector
• 00814033020047: 45-50mm Contoured Connector
• 00814033020030: 40-45mm Contoured Connector
• 00814033020023: 35-40mm Contoured Connector
• 00814033020016: 30-35mm Contoured Connector
• 00814033020009: 25-30mm Straight Connector