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FDA 510(k)

Ocata Anterior Cervical System

K-Number: K170342 · 2017-05-09

ApplicantKalitec Direct, LLC
Decision Date2017-05-09
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ocata Anterior Cervical System is a medical device manufactured by Kalitec Direct, LLC. It received FDA 510(k) clearance on 2017-05-09 under approval number K170342. 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 Ocata Anterior Cervical System?

Ocata Anterior Cervical System is a medical device that received FDA 510(k) clearance on 2017-05-09. It is manufactured by Kalitec Direct, LLC. The 510(k) number is K170342.

When was Ocata Anterior Cervical System approved by the FDA?

Ocata Anterior Cervical System received FDA 510(k) clearance on 2017-05-09, under approval number K170342.

What company makes Ocata Anterior Cervical System?

Ocata Anterior Cervical System is manufactured by Kalitec Direct, LLC.

What is the FDA product code for Ocata Anterior Cervical System?

The FDA product code for Ocata Anterior Cervical System is KWQ.

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Other Devices by Kalitec Direct, LLC

K172808CosmoLock Pedicle Screw System K172086Matira™ Anterior Cervical System K163471Kalitec Direct InSePtion™ MIS Fixation System K180401TiWAVE-C™ Porous Titanium Cervical Cage

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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