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FDA 510(k)

Hammertoe Truss System (HTS)

K-Number: K190926 · 2019-07-23

Applicant4Web, Inc.
Decision Date2019-07-23
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hammertoe Truss System (HTS) is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2019-07-23 under 510(k) number K190926. 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 Hammertoe Truss System (HTS)?

Hammertoe Truss System (HTS) is a medical device that received FDA 510(k) clearance on 2019-07-23. The listed applicant is 4Web, Inc.. The 510(k) number is K190926.

When did Hammertoe Truss System (HTS) receive FDA 510(k) clearance?

Hammertoe Truss System (HTS) received FDA 510(k) clearance on 2019-07-23, under 510(k) number K190926.

Who is the listed applicant for Hammertoe Truss System (HTS)?

The FDA 510(k) record lists 4Web, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hammertoe Truss System (HTS)?

The FDA product code for Hammertoe Truss System (HTS) is HTY.

Other records listing 4Web, Inc. as applicant

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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.

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