FDA 510(k)

CHENA-C Spacer System

K-Number: K213115 · 2021-12-06

Decision Date2021-12-06

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CHENA-C Spacer System is a medical device manufactured by Kahtnu Surgical, Inc.. It received FDA 510(k) clearance on 2021-12-06 under approval number K213115. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHENA-C Spacer System?

CHENA-C Spacer System is a medical device that received FDA 510(k) clearance on 2021-12-06. It is manufactured by Kahtnu Surgical, Inc.. The 510(k) number is K213115.

When was CHENA-C Spacer System approved by the FDA?

CHENA-C Spacer System received FDA 510(k) clearance on 2021-12-06, under approval number K213115.

What company makes CHENA-C Spacer System?

CHENA-C Spacer System is manufactured by Kahtnu Surgical, Inc..

What is the FDA product code for CHENA-C Spacer System?

The FDA product code for CHENA-C Spacer System is ODP.

Other Devices by Kahtnu Surgical, Inc.

K203154KASILOF Cervical Plate System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.