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FDA 510(k)

Tangis Anterior Cervical Plate

K-Number: K161524 · 2016-09-02

ApplicantNvision Biomedical Technologies, LLC
Decision Date2016-09-02
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tangis Anterior Cervical Plate is a medical device manufactured by Nvision Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2016-09-02 under approval number K161524. 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 Tangis Anterior Cervical Plate?

Tangis Anterior Cervical Plate is a medical device that received FDA 510(k) clearance on 2016-09-02. It is manufactured by Nvision Biomedical Technologies, LLC. The 510(k) number is K161524.

When was Tangis Anterior Cervical Plate approved by the FDA?

Tangis Anterior Cervical Plate received FDA 510(k) clearance on 2016-09-02, under approval number K161524.

What company makes Tangis Anterior Cervical Plate?

Tangis Anterior Cervical Plate is manufactured by Nvision Biomedical Technologies, LLC.

What is the FDA product code for Tangis Anterior Cervical Plate?

The FDA product code for Tangis Anterior Cervical Plate is KWQ.

Related Clinical Trials

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Other Devices by Nvision Biomedical Technologies, LLC

K162426nva, nvp, and nvt K173091Boundary Anterior Lumbar Buttress Plate K170074nvc K182949Healix™ Compression Screw System K180458FOCUS Pedicle Screw System K182943VERTEX Nitinol Staple 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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