Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is K2m. It received FDA 510(k) clearance on 2018-02-12 under 510(k) 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. The listed applicant is K2m. The 510(k) number is K172941.

When did CASCADIA Interbody System receive FDA 510(k) clearance?

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

Who is the listed applicant for CASCADIA Interbody System?

The FDA 510(k) record lists K2m as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CASCADIA Interbody System?

The FDA product code for CASCADIA Interbody System is OVD.

Other records listing K2m as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260546Q Pedicle InstrumentsK253545Vulcan Spinal SystemK252873Q Interbody InstrumentsK211320CAPRI Corpectomy Cage SystemK202528Cannulated Power Driver AttachmentK201006K2M Navigation Instruments

View all 43 devices →

Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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.

↑