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 a medical device manufactured by Neosteo. It received FDA 510(k) clearance on 2019-08-28 under approval 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. It is manufactured by Neosteo. The 510(k) number is K191424.
When was Interphalangeal Joint Fusion Device Range approved by the FDA?
Interphalangeal Joint Fusion Device Range received FDA 510(k) clearance on 2019-08-28, under approval number K191424.
What company makes Interphalangeal Joint Fusion Device Range?
Interphalangeal Joint Fusion Device Range is manufactured by Neosteo.
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.
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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.