InCore® Lapidus Sterile Kits

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 Sterile Kits.

Pre-market Notification Details

• Device ID: K190231
• 510k Number: K190231
• Device Name: InCore® Lapidus Sterile Kits
• 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: 2019-02-06
• Decision Date: 2019-05-24