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FDA 510(k)

CONSTRUX Mini PEEK Spacer System

K-Number: K202949 · 2020-10-29

ApplicantOrthofix, Inc.
Decision Date2020-10-29
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONSTRUX Mini PEEK Spacer System is a medical device manufactured by Orthofix, Inc.. It received FDA 510(k) clearance on 2020-10-29 under approval number K202949. 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 PEEK Spacer System?

CONSTRUX Mini PEEK Spacer System is a medical device that received FDA 510(k) clearance on 2020-10-29. It is manufactured by Orthofix, Inc.. The 510(k) number is K202949.

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

CONSTRUX Mini PEEK Spacer System received FDA 510(k) clearance on 2020-10-29, under approval number K202949.

What company makes CONSTRUX Mini PEEK Spacer System?

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

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

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

Other Devices by Orthofix, Inc.

K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System K162638CETRA Anterior Cervical Plate System K161129PILLAR SA PTC K161280Cervical Stand Alone System K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System K152475FORZA PTC Spacer System

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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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