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FDA 510(k)

K2M Expandable Interbody System

K-Number: K180777 · 2018-08-03

ApplicantK2m, Inc.
Decision Date2018-08-03
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

K2M Expandable Interbody System is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2018-08-03 under approval number K180777. 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 K2M Expandable Interbody System?

K2M Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by K2m, Inc.. The 510(k) number is K180777.

When was K2M Expandable Interbody System approved by the FDA?

K2M Expandable Interbody System received FDA 510(k) clearance on 2018-08-03, under approval number K180777.

What company makes K2M Expandable Interbody System?

K2M Expandable Interbody System is manufactured by K2m, Inc..

What is the FDA product code for K2M Expandable Interbody System?

The FDA product code for K2M Expandable 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 NCT07082426 Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study ACTIVE_NOT_RECRUITING

Other Devices by K2m, Inc.

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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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