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FDA 510(k)

CHENA-C Spacer System

K-Number: K213115 · 2021-12-06

ApplicantKahtnu Surgical, Inc.
Decision Date2021-12-06
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHENA-C Spacer 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 2021-12-06 under 510(k) 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. The listed applicant is Kahtnu Surgical, Inc.. The 510(k) number is K213115.

When did CHENA-C Spacer System receive FDA 510(k) clearance?

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

Who is the listed applicant for CHENA-C Spacer 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 CHENA-C Spacer System?

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

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.

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Related Devices (Code: ODP)

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.

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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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