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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 the device name listed in this FDA 510(k) record. The listed applicant is Kalitec Direct, LLC. It received FDA 510(k) clearance on 2017-05-09 under 510(k) 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. The listed applicant is Kalitec Direct, LLC. The 510(k) number is K170342.

When did Ocata Anterior Cervical System receive FDA 510(k) clearance?

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

Who is the listed applicant for Ocata Anterior Cervical System?

The FDA 510(k) record lists Kalitec Direct, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Kalitec Direct, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180401TiWAVE-C™ Porous Titanium Cervical CageK172808CosmoLock Pedicle Screw SystemK172086Matira™ Anterior Cervical SystemK163471Kalitec Direct InSePtion™ MIS Fixation System

Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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