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FDA 510(k)

EVOL ha - D Lateral Interbody Fusion System

K-Number: K192497 · 2020-01-06

ApplicantCutting Edge Spine, LLC
Decision Date2020-01-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOL ha - D Lateral Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Cutting Edge Spine, LLC. It received FDA 510(k) clearance on 2020-01-06 under 510(k) number K192497. 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 EVOL ha - D Lateral Interbody Fusion System?

EVOL ha - D Lateral Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2020-01-06. The listed applicant is Cutting Edge Spine, LLC. The 510(k) number is K192497.

When did EVOL ha - D Lateral Interbody Fusion System receive FDA 510(k) clearance?

EVOL ha - D Lateral Interbody Fusion System received FDA 510(k) clearance on 2020-01-06, under 510(k) number K192497.

Who is the listed applicant for EVOL ha - D Lateral Interbody Fusion System?

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

What is the FDA product code for EVOL ha - D Lateral Interbody Fusion System?

The FDA product code for EVOL ha - D Lateral Interbody Fusion System is MAX.

Related Clinical Trials

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.

NCT06904898CONDUIT vs. PEEK CagesACTIVE_NOT_RECRUITING

Other records listing Cutting Edge Spine, 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.

K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemK230689T-FIX™ 3DSI Joint Fusion SystemK214123T-FIX® 3DSI Joint Fusion SystemK200991EVOL Spinal Interbody SystemK200552EVOS Lumbar Interbody SystemK190025EVOL® -SI Joint Fusion System

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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.

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