Cleared Special

Drill Guide; Drill Bit; Spine & Trauma Navigation

K240701 · Brainlab AG · Orthopedic
May 2024
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K240701 is an FDA 510(k) clearance for the Drill Guide; Drill Bit; Spine & Trauma Navigation, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on May 23, 2024, 70 days after receiving the submission on March 14, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K240701 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2024
Decision Date May 23, 2024
Days to Decision 70 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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