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FDA 510(k)

WishBone K-Wire System

K-Number: K173013 · 2017-12-14

ApplicantWishbone Medical, Inc.
Decision Date2017-12-14
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WishBone K-Wire System is the device name listed in this FDA 510(k) record. The listed applicant is Wishbone Medical, Inc.. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K173013. 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 WishBone K-Wire System?

WishBone K-Wire System is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Wishbone Medical, Inc.. The 510(k) number is K173013.

When did WishBone K-Wire System receive FDA 510(k) clearance?

WishBone K-Wire System received FDA 510(k) clearance on 2017-12-14, under 510(k) number K173013.

Who is the listed applicant for WishBone K-Wire System?

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

What is the FDA product code for WishBone K-Wire System?

The FDA product code for WishBone K-Wire System is HTY.

Other records listing Wishbone Medical, Inc. as applicant

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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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