HemiCAP MTP Resurfacing Hemi-Arthroplasty System

Prosthesis, Toe, Hemi-, Phalangeal

ARTHROSURFACE, INC.

The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Hemicap Mtp Resurfacing Hemi-arthroplasty System.

Pre-market Notification Details

• Device ID: K152454
• 510k Number: K152454
• Device Name: HemiCAP MTP Resurfacing Hemi-Arthroplasty System
• Classification: Prosthesis, Toe, Hemi-, Phalangeal
• Applicant: ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin, MA 02038
• Contact: Dawn J. Wilson
• Correspondent: Dawn J. Wilson; ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin, MA 02038
• Product Code: KWD
• CFR Regulation Number: 888.3730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-08-28
• Decision Date: 2016-04-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M5289L15S080A0	K152454	000
M5289L150040A0	K152454	000
M5289L150030A0	K152454	000
M5289L150020A0	K152454	000
M5289L150010A0	K152454	000