Cleared Traditional

BOSS Toe Fixation System

K190261 · Arthrosurface, Inc. · Orthopedic
Aug 2019
Decision
187d
Days
Class 2
Risk

About This 510(k) Submission

K190261 is an FDA 510(k) clearance for the BOSS Toe Fixation System, 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 August 14, 2019, 187 days after receiving the submission on February 8, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3730.

Submission Details

510(k) Number K190261 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2019
Decision Date August 14, 2019
Days to Decision 187 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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