AlignMATE™ Lapidus Arthrodesis System

Plate, Fixation, Bone

ARTHROSURFACE, INC.

The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Alignmate™ Lapidus Arthrodesis System.

Pre-market Notification Details

• Device ID: K162391
• 510k Number: K162391
• Device Name: AlignMATE™ Lapidus Arthrodesis System
• Classification: Plate, Fixation, Bone
• Applicant: ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin, MA 02038
• Contact: Phani Puppala
• Correspondent: Phani Puppala; ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin, MA 02038
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-26
• Decision Date: 2017-02-21
• Summary: summary