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FDA 510(k)

icotec Interbody Cage System

K-Number: K172480 · 2018-05-17

ApplicantIcotec AG
Decision Date2018-05-17
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

icotec Interbody Cage System is a medical device manufactured by Icotec AG. It received FDA 510(k) clearance on 2018-05-17 under approval number K172480. 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 icotec Interbody Cage System?

icotec Interbody Cage System is a medical device that received FDA 510(k) clearance on 2018-05-17. It is manufactured by Icotec AG. The 510(k) number is K172480.

When was icotec Interbody Cage System approved by the FDA?

icotec Interbody Cage System received FDA 510(k) clearance on 2018-05-17, under approval number K172480.

What company makes icotec Interbody Cage System?

icotec Interbody Cage System is manufactured by Icotec AG.

What is the FDA product code for icotec Interbody Cage System?

The FDA product code for icotec Interbody Cage System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Icotec AG

K151977icotec Pedicle System K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 K201587icotec Anterior Cervical Plate System K200596G21 Cement, VADER® Pedicle System K200235KONG-TL VBR System, KONG-C VBR System K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0

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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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