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FDA 510(k)

Hammerdesis™ Interphalangeal Fusion System

K-Number: K231147 · 2023-09-14

ApplicantIntelivation
Decision Date2023-09-14
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hammerdesis™ Interphalangeal Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Intelivation. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K231147. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hammerdesis™ Interphalangeal Fusion System?

Hammerdesis™ Interphalangeal Fusion System is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Intelivation. The 510(k) number is K231147.

When did Hammerdesis™ Interphalangeal Fusion System receive FDA 510(k) clearance?

Hammerdesis™ Interphalangeal Fusion System received FDA 510(k) clearance on 2023-09-14, under 510(k) number K231147.

Who is the listed applicant for Hammerdesis™ Interphalangeal Fusion System?

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

What is the FDA product code for Hammerdesis™ Interphalangeal Fusion System?

The FDA product code for Hammerdesis™ Interphalangeal Fusion System is HTY.

Other records listing Intelivation as applicant

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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Related Devices (Code: HTY)

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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.

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