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FDA 510(k)

CETRA Anterior Cervical Plate System

K-Number: K162638 · 2016-12-16

ApplicantOrthofix, Inc.
Decision Date2016-12-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CETRA Anterior Cervical Plate System is a medical device manufactured by Orthofix, Inc.. It received FDA 510(k) clearance on 2016-12-16 under approval number K162638. 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 CETRA Anterior Cervical Plate System?

CETRA Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by Orthofix, Inc.. The 510(k) number is K162638.

When was CETRA Anterior Cervical Plate System approved by the FDA?

CETRA Anterior Cervical Plate System received FDA 510(k) clearance on 2016-12-16, under approval number K162638.

What company makes CETRA Anterior Cervical Plate System?

CETRA Anterior Cervical Plate System is manufactured by Orthofix, Inc..

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

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

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Other Devices by Orthofix, Inc.

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Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC 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. K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC

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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