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FDA 510(k)

CervAlign® Anterior Cervical Plate System

K-Number: K211408 · 2021-06-23

ApplicantPioneer Surgical Technology, Inc.
Decision Date2021-06-23
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CervAlign® Anterior Cervical Plate System is a medical device manufactured by Pioneer Surgical Technology, Inc.. It received FDA 510(k) clearance on 2021-06-23 under approval number K211408. 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 CervAlign® Anterior Cervical Plate System?

CervAlign® Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2021-06-23. It is manufactured by Pioneer Surgical Technology, Inc.. The 510(k) number is K211408.

When was CervAlign® Anterior Cervical Plate System approved by the FDA?

CervAlign® Anterior Cervical Plate System received FDA 510(k) clearance on 2021-06-23, under approval number K211408.

What company makes CervAlign® Anterior Cervical Plate System?

CervAlign® Anterior Cervical Plate System is manufactured by Pioneer Surgical Technology, Inc..

What is the FDA product code for CervAlign® Anterior Cervical Plate System?

The FDA product code for CervAlign® Anterior Cervical Plate System is KWQ.

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Other Devices by Pioneer Surgical Technology, Inc.

K192396Streamline MIS Spinal Fixation System K222493CODA™ Anterior Cervical Plate System K251436Resolve Anterior Cervical Plate System

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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