ToeMATE® Hammertoe Correction System

Screw, Fixation, Bone

Arthrosurface, Inc.

The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Toemate® Hammertoe Correction System.

Pre-market Notification Details

• Device ID: K170350
• 510k Number: K170350
• Device Name: ToeMATE® Hammertoe Correction System
• Classification: Screw, Fixation, Bone
• Applicant: Arthrosurface, Inc. 28 Forge Parkway Franklin, MA 02038
• Contact: Phani Puppala
• Correspondent: Dawn J Wilson; Arthrosurface, Inc. 28 Forge Parkway Franklin, MA 02038
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-02-03
• Decision Date: 2017-03-03
• Summary: summary