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FDA 510(k)

CervAlign™ Anterior Cervical Plate System

K-Number: K183060 · 2019-01-17

ApplicantPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Decision Date2019-01-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CervAlign™ Anterior Cervical Plate System is a medical device manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It received FDA 510(k) clearance on 2019-01-17 under approval number K183060. 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 2019-01-17. It is manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K183060.

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

CervAlign™ Anterior Cervical Plate System received FDA 510(k) clearance on 2019-01-17, under approval number K183060.

What company makes CervAlign™ Anterior Cervical Plate System?

CervAlign™ Anterior Cervical Plate System is manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, 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. (Dba Rti Surgical, Inc.)

K161498Streamline OCT Occipito-Cervico-Thoracic System K153735Release Laminoplasty Fixation System K172139Streamline OCT Occipito-Cervico-Thoracic System K201497EVOS Cabling System K193468Tritium Sternal Cable Plate System K192800Streamline TL Spinal Fixation 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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