PANAMA Anterior Cervical Plate (ACP) System

Q: What is the product code of K210182?

The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.

FDA 510(k) K210182 · Flospine

Substantially Equivalent

510(k) numberK210182

Submission

Device name: PANAMA Anterior Cervical Plate (ACP) System
Applicant: Flospine
Boca Raton, FL, US
Received: January 25, 2021
Decision date: April 7, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KWQ – Appliance, Fixation, Spinal Intervertebral Body
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3060
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code KWQ

510(k)	Device	Applicant	Decision
K261309	Palisades Buttress Plate SystemKWQ · Traditional	Bethesda Medical Devices, LLC	07/16/2026SE
K252776	ARIES Anterior Cervical Plate SystemsKWQ · Traditional	ZheJiang Decans Medical Devices Co., Ltd.	05/14/2026SE
K261112	CastleLoc-P Anterior Cervical Plate SystemKWQ · Special	L&K BIOMED Co., Ltd.	05/06/2026SE
K260570	corra cervical plating systemKWQ · Traditional	Carlsmed, Inc.	04/22/2026SE
K260697	VyPlate Anterior Cervical Plate SystemKWQ · Special	Vy Spine, LLC	03/27/2026SE
K260015	ANTERIS Thoracolumbar Plate SystemKWQ · Traditional	SpineCraft	03/04/2026SE
K251940	PathLoc Lumbar Plate SystemKWQ · Traditional	L&K BIOMED Co., Ltd.	03/03/2026SE
K254182	AsterKWQ · Traditional	Osteonic Co., Ltd.	02/26/2026SE
K253201	Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special	4Web, Inc.	02/12/2026SE
K252611	aprevo® cervical plating systemKWQ · Traditional	Carlsmed, Inc.	12/22/2025SE

More from Carlsmed, Inc.

510(k)	Device	Decision
K223231	Ti-Largo Cervical Interbody SystemODP · Traditional	02/24/2023SE
K193255	Largo PEEK Interbody SystemMAX · Traditional	02/20/2020SE
K141850	Flospine Pedicle Screw SystemNKB · Traditional	10/27/2014SE

Questions and answers

When was PANAMA Anterior Cervical Plate (ACP) System cleared by the FDA?

PANAMA Anterior Cervical Plate (ACP) System (K210182) received a 510(k) decision of Substantially Equivalent on April 7, 2021, 72 days after the submission was received.

What is the product code of K210182?

The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.

PANAMA Anterior Cervical Plate (ACP) System