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FDA 510(k)

Cascadia Interbody System

K-Number: K162264 · 2016-09-21

ApplicantK2m, Inc.
Decision Date2016-09-21
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cascadia Interbody System is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2016-09-21 under approval number K162264. The device is classified under product code MAX. 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 2016-09-21. It is manufactured by K2m, Inc.. The 510(k) number is K162264.

When was Cascadia Interbody System approved by the FDA?

Cascadia Interbody System received FDA 510(k) clearance on 2016-09-21, under approval number K162264.

What company makes Cascadia Interbody System?

Cascadia Interbody System is manufactured by K2m, Inc..

What is the FDA product code for Cascadia Interbody System?

The FDA product code for Cascadia Interbody System is MAX.

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, Inc.

K162664Pyrenees Cervical Plate System K161028K2M Growing Spine System K160208NILE Alternative Fixation Spinal System K172009Cascadia Interbody System K171832Range/Denali/Mesa Spinal System K172104Ozark(tm) Cervical Plate System

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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.

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