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FDA 510(k)

Partial Flex

K-Number: K242897 · 2025-06-03

ApplicantClemde SA DE CV
Decision Date2025-06-03
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Partial Flex is a medical device manufactured by Clemde SA DE CV. It received FDA 510(k) clearance on 2025-06-03 under approval number K242897. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Partial Flex?

Partial Flex is a medical device that received FDA 510(k) clearance on 2025-06-03. It is manufactured by Clemde SA DE CV. The 510(k) number is K242897.

When was Partial Flex approved by the FDA?

Partial Flex received FDA 510(k) clearance on 2025-06-03, under approval number K242897.

What company makes Partial Flex?

Partial Flex is manufactured by Clemde SA DE CV.

What is the FDA product code for Partial Flex?

The FDA product code for Partial Flex is EBI.

Other Devices by Clemde SA DE CV

K233171PF Keep; Cad Cam Keep Block

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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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