Cleared Traditional

BonOs Inject, Pedicle screw kits, Cement pusher

K202458 · Osartis GmbH · Orthopedic
May 2021
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K202458 is an FDA 510(k) clearance for the BonOs Inject, Pedicle screw kits, Cement pusher, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Osartis GmbH (M?nster, DE). The FDA issued a Cleared decision on May 18, 2021, 264 days after receiving the submission on August 27, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K202458 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2020
Decision Date May 18, 2021
Days to Decision 264 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LOD — Bone Cement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027

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