FDA 510(k)

BONE WIRE

K-Number: K030665 · 2003-03-25

Decision Date2003-03-25

Product CodeHTY

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BONE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Stork Instrumente GmbH. It received FDA 510(k) clearance on 2003-03-25 under 510(k) number K030665. 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 BONE WIRE?

BONE WIRE is a medical device that received FDA 510(k) clearance on 2003-03-25. The listed applicant is Stork Instrumente GmbH. The 510(k) number is K030665.

When did BONE WIRE receive FDA 510(k) clearance?

BONE WIRE received FDA 510(k) clearance on 2003-03-25, under 510(k) number K030665.

Who is the listed applicant for BONE WIRE?

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

What is the FDA product code for BONE WIRE?

The FDA product code for BONE WIRE 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.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions 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 Technologies

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.