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FDA 510(k)

CONSTRUX Mini Ti Spacer System

K-Number: K203342 · 2021-03-18

ApplicantOrthofix, Inc.
Decision Date2021-03-18
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONSTRUX Mini Ti Spacer System is a medical device manufactured by Orthofix, Inc.. It received FDA 510(k) clearance on 2021-03-18 under approval 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. It is manufactured by Orthofix, Inc.. The 510(k) number is K203342.

When was CONSTRUX Mini Ti Spacer System approved by the FDA?

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

What company makes CONSTRUX Mini Ti Spacer System?

CONSTRUX Mini Ti Spacer System is manufactured by Orthofix, Inc..

What is the FDA product code for CONSTRUX Mini Ti Spacer System?

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

Other Devices by Orthofix, Inc.

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Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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