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FDA 510(k)

G3(TM) Active Plate(R) Small Fragment System

K-Number: K160633 · 2016-04-22

ApplicantGenesis Fracture Care, Inc.
Decision Date2016-04-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G3(TM) Active Plate(R) Small Fragment System is a medical device manufactured by Genesis Fracture Care, Inc.. It received FDA 510(k) clearance on 2016-04-22 under approval number K160633. 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(TM) Active Plate(R) Small Fragment System?

G3(TM) Active Plate(R) Small Fragment System is a medical device that received FDA 510(k) clearance on 2016-04-22. It is manufactured by Genesis Fracture Care, Inc.. The 510(k) number is K160633.

When was G3(TM) Active Plate(R) Small Fragment System approved by the FDA?

G3(TM) Active Plate(R) Small Fragment System received FDA 510(k) clearance on 2016-04-22, under approval number K160633.

What company makes G3(TM) Active Plate(R) Small Fragment System?

G3(TM) Active Plate(R) Small Fragment System is manufactured by Genesis Fracture Care, Inc..

What is the FDA product code for G3(TM) Active Plate(R) Small Fragment System?

The FDA product code for G3(TM) Active Plate(R) Small Fragment System is HRS.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Genesis Fracture Care, Inc.

K171293G3™ Active Plate® Miniature System

Related Devices (Code: HRS)

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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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