Cleared Abbreviated

Resolve Anterior Cervical Plate System

K251436 · Pioneer Surgical Technology, Inc. · Orthopedic
Jul 2025
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K251436 is an FDA 510(k) clearance for the Resolve Anterior Cervical Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on July 11, 2025, 64 days after receiving the submission on May 8, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K251436 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2025
Decision Date July 11, 2025
Days to Decision 64 days
Submission Type Abbreviated
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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