InCore® Lapidus System

Screw, Fixation, Bone

Nextremity Solutions, Inc.

The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Incore® Lapidus System.

Pre-market Notification Details

• Device ID: K180257
• 510k Number: K180257
• Device Name: InCore® Lapidus System
• Classification: Screw, Fixation, Bone
• Applicant: Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw, IN 46580
• Contact: Greg Denham
• Correspondent: Greg Denham; Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw, IN 46580
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-01-30
• Decision Date: 2018-04-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817701021179	K180257	000
00817701020998	K180257	000
00817701020981	K180257	000
00817701020974	K180257	000
00817701020967	K180257	000
00817701020950	K180257	000
00817701020943	K180257	000
00817701020936	K180257	000
00817701020929	K180257	000
00817701020912	K180257	000
00817701020905	K180257	000
00817701020899	K180257	000
00817701020882	K180257	000
00817701020875	K180257	000
00817701021001	K180257	000
00817701021018	K180257	000
00817701021162	K180257	000
00817701021131	K180257	000
00817701021124	K180257	000
00817701021117	K180257	000
00817701021100	K180257	000
00817701021094	K180257	000
00817701021087	K180257	000
00817701021070	K180257	000
00817701021063	K180257	000
00817701021056	K180257	000
00817701021049	K180257	000
00817701021032	K180257	000
00817701021025	K180257	000
00817701020868	K180257	000