Cleared Traditional

Arthrosurface Bone Screws

K172383 · Arthrosurface, Inc. · Orthopedic
Dec 2017
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K172383 is an FDA 510(k) clearance for the Arthrosurface Bone Screws, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on December 22, 2017, 136 days after receiving the submission on August 8, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K172383 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2017
Decision Date December 22, 2017
Days to Decision 136 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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