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FDA 510(k)

Neo Cage System

K-Number: K191796 · 2019-12-13

ApplicantNeo Medical SA
Decision Date2019-12-13
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Neo Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Neo Medical SA. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K191796. 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 Neo Cage System?

Neo Cage System is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Neo Medical SA. The 510(k) number is K191796.

When did Neo Cage System receive FDA 510(k) clearance?

Neo Cage System received FDA 510(k) clearance on 2019-12-13, under 510(k) number K191796.

Who is the listed applicant for Neo Cage System?

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

What is the FDA product code for Neo Cage System?

The FDA product code for Neo Cage System is MAX.

Other records listing Neo Medical SA 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.

K243693NEO Pedicle Screw System™K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemK181048Neo Cage System TMK171582NEO Pedicle Screw 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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