Cleared Traditional

Admiral ACP System

K212139 · SeaSpine Orthopedics Corporation · Orthopedic
Sep 2021
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K212139 is an FDA 510(k) clearance for the Admiral ACP System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on September 1, 2021, 55 days after receiving the submission on July 8, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K212139 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2021
Decision Date September 01, 2021
Days to Decision 55 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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