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FDA 510(k)

Revolution External Plating System

K-Number: K181630 · 2019-05-29

ApplicantNew Standard Device Dba Metalogix
Decision Date2019-05-29
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Revolution External Plating System is a medical device manufactured by New Standard Device Dba Metalogix. It received FDA 510(k) clearance on 2019-05-29 under approval number K181630. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Revolution External Plating System?

Revolution External Plating System is a medical device that received FDA 510(k) clearance on 2019-05-29. It is manufactured by New Standard Device Dba Metalogix. The 510(k) number is K181630.

When was Revolution External Plating System approved by the FDA?

Revolution External Plating System received FDA 510(k) clearance on 2019-05-29, under approval number K181630.

What company makes Revolution External Plating System?

Revolution External Plating System is manufactured by New Standard Device Dba Metalogix.

What is the FDA product code for Revolution External Plating System?

The FDA product code for Revolution External Plating System is KTT.

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Other Devices by New Standard Device Dba Metalogix

K233025Revolution External Plating System

Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.

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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