CalcShift™ Displacement Calcaneal Osteotomy 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 Calcshift™ Displacement Calcaneal Osteotomy System.

Pre-market Notification Details

• Device ID: K212979
• 510k Number: K212979
• Device Name: CalcShift™ Displacement Calcaneal Osteotomy System
• Classification: Plate, Fixation, Bone
• Applicant: Nextremity Solutions, Inc. 1195 Polk Drive Warsaw, IN 46582
• Contact: Elise Fox
• Correspondent: Elise Fox; Nextremity Solutions, Inc. 1195 Polk Drive Warsaw, IN 46582
• Product Code: HRS
• Subsequent Product Code: HWC
• Subsequent Product Code: LXH
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-17
• Decision Date: 2022-05-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810082898538	K212979	000
00810082898521	K212979	000
00810082898194	K212979	000