Cleared Traditional

PANAMA? Anterior Cervical Plate (ACP) System

K210182 · Flospine · Orthopedic

Apr 2021

Decision

72d

Days

Class 2

Risk

About This 510(k) Submission

K210182 is an FDA 510(k) clearance for the PANAMA? Anterior Cervical Plate (ACP) System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Flospine (Boca Raton, US). The FDA issued a Cleared decision on April 7, 2021, 72 days after receiving the submission on January 25, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K210182 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 2021
Decision Date	April 07, 2021
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF