FDA 510(k)

Altus Spine Titanium Interbody Fusion System

K-Number: K170512 · 2017-03-10

Decision Date2017-03-10

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Altus Spine Titanium 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 2017-03-10 under 510(k) number K170512. 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 Titanium Interbody Fusion System?

Altus Spine Titanium Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is Altus Partners, LLC. The 510(k) number is K170512.

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

Altus Spine Titanium Interbody Fusion System received FDA 510(k) clearance on 2017-03-10, under 510(k) number K170512.

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

The FDA product code for Altus Spine Titanium Interbody Fusion System is MAX.

Related Clinical Trials

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Other records listing Altus Partners, LLC as applicant

K243419Altus Spine Navigation System K211027Altus Spine Pedicle Screw System K211837Altus Spine Interbody Standalone Fusion System K210887Altus Spine Sochi OCT Spinal System K200922Altus Spine HA Pedicle Screw System K200322Altus Spine Pedicle Screw System

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Related Devices (Code: MAX)

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 Corporation K253151Fule 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.