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FDA 510(k)

SALVATION(R) External Fixation System

K-Number: K153635 · 2016-01-13

ApplicantWrightmedicaltechnologyinc
Decision Date2016-01-13
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SALVATION(R) External Fixation System is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2016-01-13 under approval number K153635. 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(R) External Fixation System?

SALVATION(R) External Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-13. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K153635.

When was SALVATION(R) External Fixation System approved by the FDA?

SALVATION(R) External Fixation System received FDA 510(k) clearance on 2016-01-13, under approval number K153635.

What company makes SALVATION(R) External Fixation System?

SALVATION(R) External Fixation System is manufactured by Wrightmedicaltechnologyinc.

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

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

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING NCT07287124 A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults RECRUITING

Other Devices by Wrightmedicaltechnologyinc

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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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