Cleared Traditional

AccuFit Lateral 2-Hole Plate

K220324 · Precision Spine, Inc. · Orthopedic
Mar 2022
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K220324 is an FDA 510(k) clearance for the AccuFit Lateral 2-Hole Plate, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on March 16, 2022, 41 days after receiving the submission on February 3, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K220324 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2022
Decision Date March 16, 2022
Days to Decision 41 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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