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FDA 510(k)

CyclaPlex Correction System

K-Number: K183094 · 2019-04-26

ApplicantCycla Orthopedics, Ltd.
Decision Date2019-04-26
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CyclaPlex Correction System is a medical device manufactured by Cycla Orthopedics, Ltd.. It received FDA 510(k) clearance on 2019-04-26 under approval 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. It is manufactured by Cycla Orthopedics, Ltd.. The 510(k) number is K183094.

When was CyclaPlex Correction System approved by the FDA?

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

What company makes CyclaPlex Correction System?

CyclaPlex Correction System is manufactured by Cycla Orthopedics, Ltd..

What is the FDA product code for CyclaPlex Correction System?

The FDA product code for CyclaPlex Correction System is HTN.

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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.

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