Cleared Traditional

HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT

K131377 · Arthrosurface, Inc. · Orthopedic
Nov 2013
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K131377 is an FDA 510(k) clearance for the HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT, a Prosthesis, Toe, Hemi-, Phalangeal (Class II — Special Controls, product code KWD), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on November 19, 2013, 189 days after receiving the submission on May 14, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3730.

Submission Details

510(k) Number K131377 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2013
Decision Date November 19, 2013
Days to Decision 189 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWD — Prosthesis, Toe, Hemi-, Phalangeal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3730

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