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FDA 510(k)

CASCADIA Interbody System

K-Number: K172941 · 2018-02-12

ApplicantK2m
Decision Date2018-02-12
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CASCADIA Interbody System is a medical device manufactured by K2m. It received FDA 510(k) clearance on 2018-02-12 under approval number K172941. The device is classified under product code OVD. 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 2018-02-12. It is manufactured by K2m. The 510(k) number is K172941.

When was CASCADIA Interbody System approved by the FDA?

CASCADIA Interbody System received FDA 510(k) clearance on 2018-02-12, under approval number K172941.

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 OVD.

Related Clinical Trials

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Other Devices by K2m

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Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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