Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KASILOF Cervical Plate System

K-Number: K203154 · 2020-11-05

ApplicantKahtnu Surgical, Inc.
Decision Date2020-11-05
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KASILOF Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Kahtnu Surgical, Inc.. It received FDA 510(k) clearance on 2020-11-05 under 510(k) number K203154. 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 KASILOF Cervical Plate System?

KASILOF Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Kahtnu Surgical, Inc.. The 510(k) number is K203154.

When did KASILOF Cervical Plate System receive FDA 510(k) clearance?

KASILOF Cervical Plate System received FDA 510(k) clearance on 2020-11-05, under 510(k) number K203154.

Who is the listed applicant for KASILOF Cervical Plate System?

The FDA 510(k) record lists Kahtnu Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KASILOF Cervical Plate System?

The FDA product code for KASILOF Cervical Plate System is KWQ.

Other records listing Kahtnu Surgical, Inc. 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.

K213115CHENA-C Spacer 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

View on FDA Database →

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

↑