Cleared Traditional

Osteorevive

K212991 · Bone Solutions, Inc. · Orthopedic
Jan 2022
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K212991 is an FDA 510(k) clearance for the Osteorevive, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Bone Solutions, Inc. (Colleyville, US). The FDA issued a Cleared decision on January 21, 2022, 123 days after receiving the submission on September 20, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K212991 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2021
Decision Date January 21, 2022
Days to Decision 123 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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