Revolution™ Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

Intelligent Implant Systems, LLC

The following data is part of a premarket notification filed by Intelligent Implant Systems, Llc with the FDA for Revolution™ Spinal Fixation System.

Pre-market Notification Details

• Device ID: K163056
• 510k Number: K163056
• Device Name: Revolution™ Spinal Fixation System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Intelligent Implant Systems, LLC 3300 International Airport Drive, Suite 1100 Charlotte, NC 28208
• Contact: Michael Nutt
• Correspondent: Michael Nutt; Intelligent Implant Systems, LLC 3300 International Airport Drive, Suite 1100 Charlotte, NC 28208
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-01
• Decision Date: 2017-02-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00814033020764	K163056	000
00814033020498	K163056	000
00814033020481	K163056	000
00814033020474	K163056	000
00814033020467	K163056	000
00814033020450	K163056	000
00814033020443	K163056	000
00814033020436	K163056	000
00814033020429	K163056	000
00814033020412	K163056	000
00814033020405	K163056	000
00814033020399	K163056	000
00814033020382	K163056	000
00814033020375	K163056	000
00814033020368	K163056	000
00814033020351	K163056	000
00814033020344	K163056	000
00814033020504	K163056	000
00814033020511	K163056	000
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00814033020757	K163056	000
00814033020740	K163056	000
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00814033020719	K163056	000
00814033020702	K163056	000
00814033020658	K163056	000
00814033020641	K163056	000
00814033020603	K163056	000
00814033020597	K163056	000
00814033020580	K163056	000
00814033020573	K163056	000
00814033020566	K163056	000
00814033020559	K163056	000
00814033020542	K163056	000
00814033020535	K163056	000
00814033020337	K163056	000