Cleared Traditional

SCS 17-01

K173008 · Anika Therapeutics, Inc. · Orthopedic
Dec 2017
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K173008 is an FDA 510(k) clearance for the SCS 17-01, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Anika Therapeutics, Inc. (Beford, US). The FDA issued a Cleared decision on December 26, 2017, 90 days after receiving the submission on September 27, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K173008 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2017
Decision Date December 26, 2017
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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