FDA 510(k)

PILLAR SA Ti Spacer System (82-XXX)

Número K: K240749 · 2024-05-28

Data da decisão2024-05-28

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PILLAR SA Ti Spacer System (82-XXX) is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2024-05-28 under 510(k) number K240749. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PILLAR SA Ti Spacer System (82-XXX)?

PILLAR SA Ti Spacer System (82-XXX) is a medical device that received FDA 510(k) clearance on 2024-05-28. The listed applicant is Orthofix, Inc.. The 510(k) number is K240749.

When did PILLAR SA Ti Spacer System (82-XXX) receive FDA 510(k) clearance?

PILLAR SA Ti Spacer System (82-XXX) received FDA 510(k) clearance on 2024-05-28, under 510(k) number K240749.

Who is the listed applicant for PILLAR SA Ti Spacer System (82-XXX)?

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 Ti Spacer System (82-XXX)?

The FDA product code for PILLAR SA Ti Spacer System (82-XXX) is MAX.

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Outros registros que listam Orthofix, Inc. como candidato(a)

K211704CONSTRUX 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 System K211710Ascent 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 System K210667FIREBIRD SI Fusion System K203342CONSTRUX Mini Ti Spacer System K203576FORZA Ti Spacer System K203138FIREBIRD SI Fusion System

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Fonte oficial

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