Cleared Special

Inion BioRestore

K191764 · Inion OY · Orthopedic
Jul 2019
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K191764 is an FDA 510(k) clearance for the Inion BioRestore, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on July 31, 2019, 30 days after receiving the submission on July 1, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K191764 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2019
Decision Date July 31, 2019
Days to Decision 30 days
Submission Type Special
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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