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FDA 510(k)

PILLAR SA PTC

K-Number: K161129 · 2016-09-08

ApplicantOrthofix, Inc.
Decision Date2016-09-08
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PILLAR SA PTC is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) 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. The listed applicant is Orthofix, Inc.. The 510(k) number is K161129.

When did PILLAR SA PTC receive FDA 510(k) clearance?

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

Who is the listed applicant for PILLAR SA PTC?

The FDA 510(k) record lists Orthofix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PILLAR SA PTC?

The FDA product code for PILLAR SA PTC is OVD.

Related Clinical Trials

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NCT07282067Orthofix PhysioStim PEMF Ankle Fusion RetrospectiveACTIVE_NOT_RECRUITING

Other records listing Orthofix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240749PILLAR SA Ti Spacer System (82-XXX)PMA P850007Stimulator, bone growth, non-invasivePMA P030034Stimulator, bone growth, non-invasiveK211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion SystemK211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion SystemK210667FIREBIRD SI Fusion System

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Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus 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.

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