FDA 510(k)

Syntorr K-wire and Pin System

K-Number: K161489 · 2016-09-16

Decision Date2016-09-16

Product CodeHTY

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Syntorr K-wire and Pin System is the device name listed in this FDA 510(k) record. The listed applicant is Syntorr, Inc.. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K161489. 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 Syntorr K-wire and Pin System?

Syntorr K-wire and Pin System is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Syntorr, Inc.. The 510(k) number is K161489.

When did Syntorr K-wire and Pin System receive FDA 510(k) clearance?

Syntorr K-wire and Pin System received FDA 510(k) clearance on 2016-09-16, under 510(k) number K161489.

Who is the listed applicant for Syntorr K-wire and Pin System?

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

What is the FDA product code for Syntorr K-wire and Pin System?

The FDA product code for Syntorr K-wire and Pin System is HTY.

Related Devices (Code: HTY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.