FDA 510(k)

CONSTRUX Mini Ti Spacer System

K-Number: K203342 · 2021-03-18

Decision Date2021-03-18

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

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.

NCT07282067Orthofix PhysioStim PEMF Ankle Fusion RetrospectiveACTIVE_NOT_RECRUITING

Other records listing Orthofix, Inc. as applicant

K240749PILLAR SA Ti Spacer System (82-XXX)PMA P850007Stimulator, bone growth, non-invasive PMA P030034Stimulator, bone growth, non-invasive 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

View all 33 devices →

Related Devices (Code: ODP)

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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.