Cleared Traditional

ARTHROSURFACE TOEMOTION

K132496 · Arthrosurface, Inc. · Orthopedic
Feb 2014
Decision
201d
Days
—
Risk

About This 510(k) Submission

K132496 is an FDA 510(k) clearance for the ARTHROSURFACE TOEMOTION, a Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained, submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on February 26, 2014, 201 days after receiving the submission on August 9, 2013. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K132496 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2013
Decision Date February 26, 2014
Days to Decision 201 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LZJ — Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained
Device Class —

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