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)

Keos Lumbar IBFD

K-Number: K163386 · 2017-04-10

ApplicantKeos
Decision Date2017-04-10
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Keos Lumbar IBFD is the device name listed in this FDA 510(k) record. The listed applicant is Keos. It received FDA 510(k) clearance on 2017-04-10 under 510(k) number K163386. 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 Keos Lumbar IBFD?

Keos Lumbar IBFD is a medical device that received FDA 510(k) clearance on 2017-04-10. The listed applicant is Keos. The 510(k) number is K163386.

When did Keos Lumbar IBFD receive FDA 510(k) clearance?

Keos Lumbar IBFD received FDA 510(k) clearance on 2017-04-10, under 510(k) number K163386.

Who is the listed applicant for Keos Lumbar IBFD?

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

What is the FDA product code for Keos Lumbar IBFD?

The FDA product code for Keos Lumbar IBFD is MAX.

Other records listing Keos 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.

K212450Keos Anterior Cervical Interbody Fusion Device SystemK193174Keos Lumbar IBFDK160631Keos Lumbar IBFD

Related Devices (Code: MAX)

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.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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.

↑