PANAMA™ Anterior Cervical Plate (ACP) System

Appliance, Fixation, Spinal Intervertebral Body

FloSpine

The following data is part of a premarket notification filed by Flospine with the FDA for Panama™ Anterior Cervical Plate (acp) System.

Pre-market Notification Details

• Device ID: K210182
• 510k Number: K210182
• Device Name: PANAMA™ Anterior Cervical Plate (ACP) System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: FloSpine 3651 FAU Blvd.., Suite 400 Boca Raton, FL 33431
• Contact: Peter Harris
• Correspondent: Robert A Poggie; BioVera, Inc. 65 Promenade Saint Louis Notre-dame-de-l'lle-perrot, CA J7v7p2
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-01-25
• Decision Date: 2021-04-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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