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FDA 510(k)

AERIAL™ Interspinous Fixation

K-Number: K180817 · 2018-05-21

ApplicantGlobus Medical, Inc.
Decision Date2018-05-21
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AERIAL™ Interspinous Fixation is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2018-05-21 under approval number K180817. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AERIAL™ Interspinous Fixation?

AERIAL™ Interspinous Fixation is a medical device that received FDA 510(k) clearance on 2018-05-21. It is manufactured by Globus Medical, Inc.. The 510(k) number is K180817.

When was AERIAL™ Interspinous Fixation approved by the FDA?

AERIAL™ Interspinous Fixation received FDA 510(k) clearance on 2018-05-21, under approval number K180817.

What company makes AERIAL™ Interspinous Fixation?

AERIAL™ Interspinous Fixation is manufactured by Globus Medical, Inc..

What is the FDA product code for AERIAL™ Interspinous Fixation?

The FDA product code for AERIAL™ Interspinous Fixation is PEK.

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Related Devices (Code: PEK)

K161016Z-Clamp ISP SystemZavation, LLC K153302coflex-IFParadigm Spine, LLC K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc. K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC K162849Huvex Interspinous Fixation SystemDio Medical Co., Ltd.

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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