Cleared Special

Cirq Arm System (2.0);Alignment System Spine

K222966 · Brainlab AG · Orthopedic
Oct 2022
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K222966 is an FDA 510(k) clearance for the Cirq Arm System (2.0);Alignment System Spine, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on October 27, 2022, 30 days after receiving the submission on September 27, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K222966 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2022
Decision Date October 27, 2022
Days to Decision 30 days
Submission Type Special
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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