Cleared Traditional

HydroSet XT

K161447 · Orthovita, Inc. · Orthopedic
Oct 2016
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K161447 is an FDA 510(k) clearance for the HydroSet XT, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Orthovita, Inc. (Malver, US). The FDA issued a Cleared decision on October 6, 2016, 134 days after receiving the submission on May 25, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K161447 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2016
Decision Date October 06, 2016
Days to Decision 134 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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