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FDA 510(k)

Integra External Fixation System

K-Number: K160830 · 2016-07-06

ApplicantAscension Orthopedics
Decision Date2016-07-06
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Integra External Fixation System is a medical device manufactured by Ascension Orthopedics. It received FDA 510(k) clearance on 2016-07-06 under approval number K160830. 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 Integra External Fixation System?

Integra External Fixation System is a medical device that received FDA 510(k) clearance on 2016-07-06. It is manufactured by Ascension Orthopedics. The 510(k) number is K160830.

When was Integra External Fixation System approved by the FDA?

Integra External Fixation System received FDA 510(k) clearance on 2016-07-06, under approval number K160830.

What company makes Integra External Fixation System?

Integra External Fixation System is manufactured by Ascension Orthopedics.

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

The FDA product code for Integra 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 NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING

Other Devices by Ascension Orthopedics

K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System K182878Integra Salto Total Ankle System

Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, Inc. K151580D.N.E. External Fixation SystemDne, LLC

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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