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)

ZipToe™ Hammertoe Fusion System

K-Number: K253325 · 2025-12-29

ApplicantToetal Solutions
Decision Date2025-12-29
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZipToe™ Hammertoe Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Toetal Solutions. It received FDA 510(k) clearance on 2025-12-29 under 510(k) number K253325. 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 ZipToe™ Hammertoe Fusion System?

ZipToe™ Hammertoe Fusion System is a medical device that received FDA 510(k) clearance on 2025-12-29. The listed applicant is Toetal Solutions. The 510(k) number is K253325.

When did ZipToe™ Hammertoe Fusion System receive FDA 510(k) clearance?

ZipToe™ Hammertoe Fusion System received FDA 510(k) clearance on 2025-12-29, under 510(k) number K253325.

Who is the listed applicant for ZipToe™ Hammertoe Fusion System?

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

What is the FDA product code for ZipToe™ Hammertoe Fusion System?

The FDA product code for ZipToe™ Hammertoe Fusion System 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.

K252657Impact 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.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.

↑