Cleared Traditional

Taps for Resorbable Screws

K153587 · Synthes USA Products, LLC · Neurology
Jan 2017
Decision
399d
Days
Class 2
Risk

About This 510(k) Submission

K153587 is an FDA 510(k) clearance for the Taps for Resorbable Screws, a Drills, Burrs, Trephines & Accessories (manual) (Class II — Special Controls, product code HBG), submitted by Synthes USA Products, LLC (19380, US). The FDA issued a Cleared decision on January 18, 2017, 399 days after receiving the submission on December 16, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4300.

Submission Details

510(k) Number K153587 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2015
Decision Date January 18, 2017
Days to Decision 399 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBG — Drills, Burrs, Trephines & Accessories (manual)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4300

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