Cleared Traditional

ApolloKnee

K231172 · Corin U.S.A. Limited · Orthopedic

Jul 2023

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K231172 is an FDA 510(k) clearance for the ApolloKnee, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Corin U.S.A. Limited (Tampa, US). The FDA issued a Cleared decision on July 26, 2023, 92 days after receiving the submission on April 25, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K231172 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 2023
Decision Date	July 26, 2023
Days to Decision	92 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.