FDA 510(k)

CyclaPlex Correction System

K-Number: K183094 · 2019-04-26

Decision Date2019-04-26

Product CodeHTN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CyclaPlex Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Cycla Orthopedics, Ltd.. It received FDA 510(k) clearance on 2019-04-26 under 510(k) number K183094. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CyclaPlex Correction System?

CyclaPlex Correction System is a medical device that received FDA 510(k) clearance on 2019-04-26. The listed applicant is Cycla Orthopedics, Ltd.. The 510(k) number is K183094.

When did CyclaPlex Correction System receive FDA 510(k) clearance?

CyclaPlex Correction System received FDA 510(k) clearance on 2019-04-26, under 510(k) number K183094.

Who is the listed applicant for CyclaPlex Correction System?

The FDA 510(k) record lists Cycla Orthopedics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CyclaPlex Correction System?

The FDA product code for CyclaPlex Correction System is HTN.

Related Devices (Code: HTN)

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.