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FDA 510(k)

Largo PEEK Interbody System

K-Number: K193255 · 2020-02-20

ApplicantFlospine, LLC
Decision Date2020-02-20
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Largo PEEK Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Flospine, LLC. It received FDA 510(k) clearance on 2020-02-20 under 510(k) number K193255. 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 Largo PEEK Interbody System?

Largo PEEK Interbody System is a medical device that received FDA 510(k) clearance on 2020-02-20. The listed applicant is Flospine, LLC. The 510(k) number is K193255.

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

Largo PEEK Interbody System received FDA 510(k) clearance on 2020-02-20, under 510(k) number K193255.

Who is the listed applicant for Largo PEEK Interbody System?

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

What is the FDA product code for Largo PEEK Interbody System?

The FDA product code for Largo PEEK Interbody System is MAX.

Other records listing Flospine, LLC 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.

K232484KeyLift™ Expandable Interlaminar Stabilization SystemK223231Ti-Largo Cervical Interbody SystemK210182PANAMA™ Anterior Cervical Plate (ACP) System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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