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FDA 510(k)

PANAMA™ Anterior Cervical Plate (ACP) System

K-Number: K210182 · 2021-04-07

ApplicantFlospine
Decision Date2021-04-07
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PANAMA™ Anterior Cervical Plate (ACP) System is a medical device manufactured by Flospine. It received FDA 510(k) clearance on 2021-04-07 under approval number K210182. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANAMA™ Anterior Cervical Plate (ACP) System?

PANAMA™ Anterior Cervical Plate (ACP) System is a medical device that received FDA 510(k) clearance on 2021-04-07. It is manufactured by Flospine. The 510(k) number is K210182.

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

PANAMA™ Anterior Cervical Plate (ACP) System received FDA 510(k) clearance on 2021-04-07, under approval number K210182.

What company makes PANAMA™ Anterior Cervical Plate (ACP) System?

PANAMA™ Anterior Cervical Plate (ACP) System is manufactured by Flospine.

What is the FDA product code for PANAMA™ Anterior Cervical Plate (ACP) System?

The FDA product code for PANAMA™ Anterior Cervical Plate (ACP) System is KWQ.

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Other Devices by Flospine

K232484KeyLift™ Expandable Interlaminar Stabilization System K223231Ti-Largo Cervical Interbody System

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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