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FDA 510(k)

Altus Spine Interbody Fusion System

K-Number: K182406 · 2019-02-22

ApplicantAltus Partners, LLC
Decision Date2019-02-22
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Altus Spine Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Altus Partners, LLC. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K182406. 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 Altus Spine Interbody Fusion System?

Altus Spine Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Altus Partners, LLC. The 510(k) number is K182406.

When did Altus Spine Interbody Fusion System receive FDA 510(k) clearance?

Altus Spine Interbody Fusion System received FDA 510(k) clearance on 2019-02-22, under 510(k) number K182406.

Who is the listed applicant for Altus Spine Interbody Fusion System?

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

What is the FDA product code for Altus Spine Interbody Fusion System?

The FDA product code for Altus Spine 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.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITING

Other records listing Altus Partners, 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.

K243419Altus Spine Navigation SystemK211027Altus Spine Pedicle Screw SystemK211837Altus Spine Interbody Standalone Fusion SystemK210887Altus Spine Sochi OCT Spinal SystemK200922Altus Spine HA Pedicle Screw SystemK200322Altus Spine Pedicle Screw 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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