Cleared Traditional

SeaSpine 7D Navigation Instruments

K222753 · SeaSpine Orthopedics Corporation · Orthopedic
Dec 2022
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K222753 is an FDA 510(k) clearance for the SeaSpine 7D Navigation Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on December 9, 2022, 88 days after receiving the submission on September 12, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K222753 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2022
Decision Date December 09, 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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