FDA 510(k)

PILLAR SA PTC

K-Number: K161129 · 2016-09-08

Decision Date2016-09-08

Product CodeOVD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PILLAR SA PTC is a medical device manufactured by Orthofix, Inc.. It received FDA 510(k) clearance on 2016-09-08 under approval number K161129. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PILLAR SA PTC?

PILLAR SA PTC is a medical device that received FDA 510(k) clearance on 2016-09-08. It is manufactured by Orthofix, Inc.. The 510(k) number is K161129.

When was PILLAR SA PTC approved by the FDA?

PILLAR SA PTC received FDA 510(k) clearance on 2016-09-08, under approval number K161129.

What company makes PILLAR SA PTC?

PILLAR SA PTC is manufactured by Orthofix, Inc..

What is the FDA product code for PILLAR SA PTC?

The FDA product code for PILLAR SA PTC is OVD.

Other Devices by Orthofix, Inc.

K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System K162638CETRA Anterior Cervical Plate System K161280Cervical Stand Alone System K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System K152475FORZA PTC Spacer System K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System

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Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K160597INDEPENDENCE MIS SpacersGlobus Medical, 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.