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FDA 510(k)

Formus Hip

K-Number: K213272 · 2023-03-31

ApplicantFormus Labs, Ltd.
Decision Date2023-03-31
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Formus Hip is the device name listed in this FDA 510(k) record. The listed applicant is Formus Labs, Ltd.. It received FDA 510(k) clearance on 2023-03-31 under 510(k) number K213272. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Formus Hip?

Formus Hip is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is Formus Labs, Ltd.. The 510(k) number is K213272.

When did Formus Hip receive FDA 510(k) clearance?

Formus Hip received FDA 510(k) clearance on 2023-03-31, under 510(k) number K213272.

Who is the listed applicant for Formus Hip?

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

What is the FDA product code for Formus Hip?

The FDA product code for Formus Hip is QIH.

Related Devices (Code: QIH)

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

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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