FDA 510(k)

G3 Active Plate® Miniature System

K-Number: K171293 · 2017-10-23

Decision Date2017-10-23

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

G3 Active Plate® Miniature System is a medical device manufactured by Genesis Fracture Care, Inc.. It received FDA 510(k) clearance on 2017-10-23 under approval number K171293. 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 G3 Active Plate® Miniature System?

G3 Active Plate® Miniature System is a medical device that received FDA 510(k) clearance on 2017-10-23. It is manufactured by Genesis Fracture Care, Inc.. The 510(k) number is K171293.

When was G3 Active Plate® Miniature System approved by the FDA?

G3 Active Plate® Miniature System received FDA 510(k) clearance on 2017-10-23, under approval number K171293.

What company makes G3 Active Plate® Miniature System?

G3 Active Plate® Miniature System is manufactured by Genesis Fracture Care, Inc..

What is the FDA product code for G3 Active Plate® Miniature System?

The FDA product code for G3 Active Plate® Miniature System is HRS.

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Other Devices by Genesis Fracture Care, Inc.

K160633G3(TM) Active Plate(R) Small Fragment System

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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.