FDA 510(k)

CONSTRUX Mini Ti Spacer System

Número K: K203342 · 2021-03-18

Data da decisão2021-03-18

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CONSTRUX Mini Ti Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2021-03-18 under 510(k) number K203342. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CONSTRUX Mini Ti Spacer System?

CONSTRUX Mini Ti Spacer System is a medical device that received FDA 510(k) clearance on 2021-03-18. The listed applicant is Orthofix, Inc.. The 510(k) number is K203342.

When did CONSTRUX Mini Ti Spacer System receive FDA 510(k) clearance?

CONSTRUX Mini Ti Spacer System received FDA 510(k) clearance on 2021-03-18, under 510(k) number K203342.

Who is the listed applicant for CONSTRUX Mini Ti Spacer System?

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 CONSTRUX Mini Ti Spacer System?

The FDA product code for CONSTRUX Mini Ti Spacer System is ODP.

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

K240749PILLAR SA Ti Spacer System (82-XXX)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 K203576FORZA Ti Spacer System K203138FIREBIRD SI Fusion System

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Fonte oficial

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