Stratum™ Reduced Size Foot Plating System

Plate, Fixation, Bone

Nextremity Solutions, Inc.

The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Stratum™ Reduced Size Foot Plating System.

Pre-market Notification Details

• Device ID: K200785
• 510k Number: K200785
• Device Name: Stratum™ Reduced Size Foot Plating System
• Classification: Plate, Fixation, Bone
• Applicant: Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw, IN 46580
• Contact: Adam Finley
• Correspondent: Adam Finley; Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw, IN 46580
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-26
• Decision Date: 2020-07-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817701027553	K200785	000
00817701027430	K200785	000
00817701027423	K200785	000
00817701027416	K200785	000
00817701027409	K200785	000
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00817701027362	K200785	000
00817701027447	K200785	000
00817701027454	K200785	000
00817701027461	K200785	000
00817701027546	K200785	000
00817701027539	K200785	000
00817701027522	K200785	000
00817701027515	K200785	000
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00817701027492	K200785	000
00817701027485	K200785	000
00817701027478	K200785	000
00817701027355	K200785	000
00817701027348	K200785	000
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00817701027140	K200785	000
00817701027133	K200785	000
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00817701027164	K200785	000
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00817701027188	K200785	000
00817701027331	K200785	000
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00817701027249	K200785	000
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00817701027201	K200785	000
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00817701027072	K200785	000
00817701028017	K200785	000
00817701027850	K200785	000
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00817701027836	K200785	000
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00817701027690	K200785	000
00817701027683	K200785	000
00817701027560	K200785	000