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FDA 510(k)

Cascadia Interbody System

K-Number: K160125 · 2016-04-22

ApplicantK2m
Decision Date2016-04-22
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cascadia Interbody System is a medical device manufactured by K2m. It received FDA 510(k) clearance on 2016-04-22 under approval number K160125. 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 Cascadia Interbody System?

Cascadia Interbody System is a medical device that received FDA 510(k) clearance on 2016-04-22. It is manufactured by K2m. The 510(k) number is K160125.

When was Cascadia Interbody System approved by the FDA?

Cascadia Interbody System received FDA 510(k) clearance on 2016-04-22, under approval number K160125.

What company makes Cascadia Interbody System?

Cascadia Interbody System is manufactured by K2m.

What is the FDA product code for Cascadia Interbody System?

The FDA product code for Cascadia Interbody 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 K2m

K153526Pyrenees Cervical Plate System K160547Cascadia Interbody System K152872K2M Fenestrated Tap System K171704CAPRI Corpectomy Cage System K171321K2M Navigation Instruments K170055CAPRI Corpectomy Cage 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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