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FDA 510(k)

SALVATION External Fixation System

K-Number: K162033 · 2017-03-06

ApplicantWright Medical
Decision Date2017-03-06
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SALVATION External Fixation System is a medical device manufactured by Wright Medical. It received FDA 510(k) clearance on 2017-03-06 under approval number K162033. 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 SALVATION External Fixation System?

SALVATION External Fixation System is a medical device that received FDA 510(k) clearance on 2017-03-06. It is manufactured by Wright Medical. The 510(k) number is K162033.

When was SALVATION External Fixation System approved by the FDA?

SALVATION External Fixation System received FDA 510(k) clearance on 2017-03-06, under approval number K162033.

What company makes SALVATION External Fixation System?

SALVATION External Fixation System is manufactured by Wright Medical.

What is the FDA product code for SALVATION External Fixation System?

The FDA product code for SALVATION External Fixation System is KTT.

Related Clinical Trials

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Other Devices by Wright Medical

K203228DART-FIRE EDGE Cannulated Screw System K203832FuseForce™ Flex Dynamic Compression 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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