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FDA 510(k)

DARCO Locking Bone Plate System

K-Number: K171852 · 2017-09-21

Decision Date2017-09-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DARCO Locking Bone Plate System is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2017-09-21 under approval number K171852. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DARCO Locking Bone Plate System?

DARCO Locking Bone Plate System is a medical device that received FDA 510(k) clearance on 2017-09-21. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K171852.

When was DARCO Locking Bone Plate System approved by the FDA?

DARCO Locking Bone Plate System received FDA 510(k) clearance on 2017-09-21, under approval number K171852.

What company makes DARCO Locking Bone Plate System?

DARCO Locking Bone Plate System is manufactured by Wrightmedicaltechnologyinc.

What is the FDA product code for DARCO Locking Bone Plate System?

The FDA product code for DARCO Locking Bone Plate System is HRS.

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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.