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FDA 510(k)

Medline UNITE REFLEX Dynamic Discs

K-Number: K211612 · 2021-12-10

ApplicantMedline Industries, Inc.
Decision Date2021-12-10
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE REFLEX Dynamic Discs is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-12-10 under approval number K211612. 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 Medline UNITE REFLEX Dynamic Discs?

Medline UNITE REFLEX Dynamic Discs is a medical device that received FDA 510(k) clearance on 2021-12-10. It is manufactured by Medline Industries, Inc.. The 510(k) number is K211612.

When was Medline UNITE REFLEX Dynamic Discs approved by the FDA?

Medline UNITE REFLEX Dynamic Discs received FDA 510(k) clearance on 2021-12-10, under approval number K211612.

What company makes Medline UNITE REFLEX Dynamic Discs?

Medline UNITE REFLEX Dynamic Discs is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline UNITE REFLEX Dynamic Discs?

The FDA product code for Medline UNITE REFLEX Dynamic Discs 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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