REVOLUTION SPINAL SYSTEM 1165535TL

GUDID 00814033020412

5.5 X 35 MM CANNULATED BONE SCREW, TWO-LEVEL

INTELLIGENT IMPLANT SYSTEMS, LLC

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00814033020412
• NIH Device Record Key: 5a22ff53-5835-4fc6-9df1-d656c5e5bdca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REVOLUTION SPINAL SYSTEM
• Version Model Number: 1165535TL
• Catalog Number: 1165535TL
• 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: true
• 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
• Phone: 704-424-1009
• Email: INFO@INTELLIGENTIMPLANTSYSTEMS.COM
• Phone: 704-424-1009
• Email: INFO@INTELLIGENTIMPLANTSYSTEMS.COM
• Phone: 704-424-1009
• Email: INFO@INTELLIGENTIMPLANTSYSTEMS.COM
• Phone: 704-424-1009
• Email: INFO@INTELLIGENTIMPLANTSYSTEMS.COM
• Phone: 704-424-1009
• Email: INFO@INTELLIGENTIMPLANTSYSTEMS.COM
• Phone: 704-424-1009
• Email: INFO@INTELLIGENTIMPLANTSYSTEMS.COM
• Phone: 704-424-1009
• Email: INFO@INTELLIGENTIMPLANTSYSTEMS.COM
• Phone: 704-424-1009
• Email: INFO@INTELLIGENTIMPLANTSYSTEMS.COM
• Phone: 704-424-1009
• Email: INFO@INTELLIGENTIMPLANTSYSTEMS.COM
• Phone: 704-424-1009
• Email: INFO@INTELLIGENTIMPLANTSYSTEMS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814033020412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163056

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

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: 2017-05-04

On-Brand Devices [REVOLUTION SPINAL SYSTEM]

• 00814033020894: REVOLUTION 30-35 MM ULTRA CONTOURED CONNECTOR
• 00814033020887: REVOLUTION 25-30 MM ULTRA CONTOURED CONNECTOR
• 00814033020870: REVOLUTION 20-25 MM ULTRA CONTOURED CONNECTOR
• 00814033020863: REVOLUTION 15-20 MM ULTRA CONTOURED CONNECTOR
• 00814033020764: 45-50 MM TWO-LEVEL CONTOURED CONNECTOR
• 00814033020757: 40-45 MM TWO-LEVEL CONTOURED CONNECTOR
• 00814033020740: 35-40 MM TWO-LEVEL CONTOURED CONNECTOR
• 00814033020733: 30-35 MM TWO-LEVEL CONTOURED CONNECTOR
• 00814033020726: 25-30 MM TWO-LEVEL CONTOURED CONNECTOR
• 00814033020719: 20-25 MM TWO-LEVEL CONTOURED CONNECTOR
• 00814033020702: 15-20 MM TWO-LEVEL CONTOURED CONNECTOR
• 00814033020658: 20-25 MM XTRA CONTOURED CONNECTOR
• 00814033020641: 15-20 MM XTRA CONTOURED CONNECTOR
• 00814033020603: 25-30 MM XTRA CONTOURED CONNECTOR
• 00814033020597: 7.5 X 55 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020580: 7.5 X 50 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020573: 7.5 X 45 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020566: 7.5 X 40 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020559: 7.5 X 35 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020542: 7.5 X 30 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020535: 7.5 X 25 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020528: 6.5 X 55 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020511: 6.5 X 50 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020504: 6.5 X 45 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020498: 6.5 X 40 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020481: 6.5 X 35 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020474: 6.5 X 30 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020467: 6.5 X 25 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020450: 5.5 X 55 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020443: 5.5 X 50 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020436: 5.5 X 45 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020429: 5.5 X 40 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020412: 5.5 X 35 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020405: 5.5 X 30 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020399: 5.5 X 25 MM CANNULATED BONE SCREW, TWO-LEVEL
• 00814033020382: 4.5 X 50 MM BONE SCREW, TWO-LEVEL
• 00814033020375: 4.5 X 45 MM BONE SCREW, TWO-LEVEL
• 00814033020368: 4.5 X 40 MM BONE SCREW, TWO-LEVEL
• 00814033020351: 4.5 X 35 MM BONE SCREW, TWO-LEVEL
• 00814033020344: 4.5 X 30 MM BONE SCREW, TWO-LEVEL
• 00814033020337: 4.5 x 25 MM BONE SCREW, TWO-LEVEL