Cleared Traditional

CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM

K113762 · Arthrosurface, Inc. · Orthopedic
Feb 2012
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K113762 is an FDA 510(k) clearance for the CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on February 6, 2012, 47 days after receiving the submission on December 21, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K113762 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2011
Decision Date February 06, 2012
Days to Decision 47 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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