Cleared Traditional

Nanova Interference Screw

K161174 · Nanova Biomaterials, Inc. · Orthopedic
Nov 2016
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K161174 is an FDA 510(k) clearance for the Nanova Interference Screw, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Nanova Biomaterials, Inc. (Columbia, US). The FDA issued a Cleared decision on November 3, 2016, 191 days after receiving the submission on April 26, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K161174 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2016
Decision Date November 03, 2016
Days to Decision 191 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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