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FDA 510(k)

Fuji Cervical Plate System

K-Number: K183084 · 2019-05-29

ApplicantAltus Partners, LLC
Decision Date2019-05-29
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fuji Cervical Plate System is a medical device manufactured by Altus Partners, LLC. It received FDA 510(k) clearance on 2019-05-29 under approval number K183084. 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 Fuji Cervical Plate System?

Fuji Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-05-29. It is manufactured by Altus Partners, LLC. The 510(k) number is K183084.

When was Fuji Cervical Plate System approved by the FDA?

Fuji Cervical Plate System received FDA 510(k) clearance on 2019-05-29, under approval number K183084.

What company makes Fuji Cervical Plate System?

Fuji Cervical Plate System is manufactured by Altus Partners, LLC.

What is the FDA product code for Fuji Cervical Plate System?

The FDA product code for Fuji Cervical Plate System is KWQ.

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Other Devices by Altus Partners, LLC

K170553Altus Spine Interbody Fusion System K172253Altus Spine Cervical Interbody Fusion System K171329Altus Spine Titanium Interbody Fusion System K170512Altus Spine Titanium Interbody Fusion System K163061Altus Spine Cervical Plate System K160976Altus Spine Interbody Fusion System

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Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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