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FDA 510(k)

Cortina™ [MAX] Lumbar Cage System

K-Number: K192248 · 2019-11-25

ApplicantNeurostructures, Inc.
Decision Date2019-11-25
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cortina™ [MAX] Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Neurostructures, Inc.. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K192248. 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 Cortina™ [MAX] Lumbar Cage System?

Cortina™ [MAX] Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Neurostructures, Inc.. The 510(k) number is K192248.

When did Cortina™ [MAX] Lumbar Cage System receive FDA 510(k) clearance?

Cortina™ [MAX] Lumbar Cage System received FDA 510(k) clearance on 2019-11-25, under 510(k) number K192248.

Who is the listed applicant for Cortina™ [MAX] Lumbar Cage System?

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

What is the FDA product code for Cortina™ [MAX] Lumbar Cage System?

The FDA product code for Cortina™ [MAX] Lumbar Cage System is MAX.

Other records listing Neurostructures, Inc. 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.

K202190Oculus-SA Lumbar Cage SystemK200115Cavetto-SA Cervical Cage SystemK201769Cavetto [MAX] Cervical Cage SystemK200927Transept Cervical Plate SystemK182195Arco™-SA Lumbar Cage SystemK181590Neurostructures Cavetto® [MAX] Cervical Cage 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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