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FDA 510(k)

Interphalangeal Joint Fusion Device Range

K-Number: K191424 · 2019-08-28

ApplicantNeosteo
Decision Date2019-08-28
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Interphalangeal Joint Fusion Device Range is the device name listed in this FDA 510(k) record. The listed applicant is Neosteo. It received FDA 510(k) clearance on 2019-08-28 under 510(k) number K191424. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Interphalangeal Joint Fusion Device Range?

Interphalangeal Joint Fusion Device Range is a medical device that received FDA 510(k) clearance on 2019-08-28. The listed applicant is Neosteo. The 510(k) number is K191424.

When did Interphalangeal Joint Fusion Device Range receive FDA 510(k) clearance?

Interphalangeal Joint Fusion Device Range received FDA 510(k) clearance on 2019-08-28, under 510(k) number K191424.

Who is the listed applicant for Interphalangeal Joint Fusion Device Range?

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

What is the FDA product code for Interphalangeal Joint Fusion Device Range?

The FDA product code for Interphalangeal Joint Fusion Device Range is HWC. This falls under the Cardiovascular category.

Other records listing Neosteo 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.

K212545FlexitSystem Knee osteotomy systemK192447Superelastic Staple

Related Devices (Code: HWC)

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

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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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