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FDA 510(k)

Altus Spine Cervical Plate System

K-Number: K163061 · 2017-02-06

ApplicantAltus Partners, LLC
Decision Date2017-02-06
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Altus Spine Cervical Plate 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 2017-02-06 under 510(k) number K163061. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altus Spine Cervical Plate System?

Altus Spine Cervical Plate System is a medical device that received FDA 510(k) clearance on 2017-02-06. The listed applicant is Altus Partners, LLC. The 510(k) number is K163061.

When did Altus Spine Cervical Plate System receive FDA 510(k) clearance?

Altus Spine Cervical Plate System received FDA 510(k) clearance on 2017-02-06, under 510(k) number K163061.

Who is the listed applicant for Altus Spine Cervical Plate 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 Cervical Plate System?

The FDA product code for Altus Spine Cervical Plate System is KWQ.

Related Clinical Trials

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NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

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: KWQ)

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.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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