Cleared Traditional

Knee 3

K220652 · Brainlab AG · Orthopedic
Jun 2022
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K220652 is an FDA 510(k) clearance for the Knee 3, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on June 3, 2022, 88 days after receiving the submission on March 7, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K220652 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2022
Decision Date June 03, 2022
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OLO — Orthopedic Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.

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