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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 the device name listed in this FDA 510(k) record. The listed applicant is New Standard Device Dba Metalogix. It received FDA 510(k) clearance on 2019-05-29 under 510(k) 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. The listed applicant is New Standard Device Dba Metalogix. The 510(k) number is K181630.

When did Revolution External Plating System receive FDA 510(k) clearance?

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

Who is the listed applicant for Revolution External Plating System?

The FDA 510(k) record lists New Standard Device Dba Metalogix as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing New Standard Device Dba Metalogix as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233025Revolution External Plating System

Related Devices (Code: KTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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