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)

RONAVIS – FX (FX-001)

K-Number: K250315 · 2025-08-01

ApplicantAIRS, Inc.
Decision Date2025-08-01
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RONAVIS – FX (FX-001) is the device name listed in this FDA 510(k) record. The listed applicant is AIRS, Inc.. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K250315. 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 RONAVIS – FX (FX-001)?

RONAVIS – FX (FX-001) is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is AIRS, Inc.. The 510(k) number is K250315.

When did RONAVIS – FX (FX-001) receive FDA 510(k) clearance?

RONAVIS – FX (FX-001) received FDA 510(k) clearance on 2025-08-01, under 510(k) number K250315.

Who is the listed applicant for RONAVIS – FX (FX-001)?

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

What is the FDA product code for RONAVIS – FX (FX-001)?

The FDA product code for RONAVIS – FX (FX-001) is HTY.

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.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical TechnologiesK241014Biomet Kirschner Wires (K-Wires)Biomet, Inc.K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation NailOSSIO , Ltd.

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.

↑