Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

StarFuse Interphalangeal Pin

K-Number: K160194 · 2016-04-26

ApplicantPhalanx Innovations
Decision Date2016-04-26
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

StarFuse Interphalangeal Pin is the device name listed in this FDA 510(k) record. The listed applicant is Phalanx Innovations. It received FDA 510(k) clearance on 2016-04-26 under 510(k) number K160194. 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 StarFuse Interphalangeal Pin?

StarFuse Interphalangeal Pin is a medical device that received FDA 510(k) clearance on 2016-04-26. The listed applicant is Phalanx Innovations. The 510(k) number is K160194.

When did StarFuse Interphalangeal Pin receive FDA 510(k) clearance?

StarFuse Interphalangeal Pin received FDA 510(k) clearance on 2016-04-26, under 510(k) number K160194.

Who is the listed applicant for StarFuse Interphalangeal Pin?

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

What is the FDA product code for StarFuse Interphalangeal Pin?

The FDA product code for StarFuse Interphalangeal Pin is HTY.

Other records listing Phalanx Innovations 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.

K160304OsteoBullet Compression Screw

Related Devices (Code: HTY)

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.

K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical TechnologiesK241014Biomet Kirschner Wires (K-Wires)Biomet, Inc.

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.

↑