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FDA 510(k)

Pitkar External Fixation System - Rail Mechanism

K-Number: K200518 · 2020-07-29

ApplicantS.H.Pitkar Orthotools Pvt. , Ltd.
Decision Date2020-07-29
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pitkar External Fixation System - Rail Mechanism is a medical device manufactured by S.H.Pitkar Orthotools Pvt. , Ltd.. It received FDA 510(k) clearance on 2020-07-29 under approval number K200518. 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 Pitkar External Fixation System - Rail Mechanism?

Pitkar External Fixation System - Rail Mechanism is a medical device that received FDA 510(k) clearance on 2020-07-29. It is manufactured by S.H.Pitkar Orthotools Pvt. , Ltd.. The 510(k) number is K200518.

When was Pitkar External Fixation System - Rail Mechanism approved by the FDA?

Pitkar External Fixation System - Rail Mechanism received FDA 510(k) clearance on 2020-07-29, under approval number K200518.

What company makes Pitkar External Fixation System - Rail Mechanism?

Pitkar External Fixation System - Rail Mechanism is manufactured by S.H.Pitkar Orthotools Pvt. , Ltd..

What is the FDA product code for Pitkar External Fixation System - Rail Mechanism?

The FDA product code for Pitkar External Fixation System - Rail Mechanism 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 S.H.Pitkar Orthotools Pvt. , Ltd.

K190486Pitkar External Fixation System K200728Pitkar DeftFix System K192619Pitkar Locked Plating System K240233Pitkar Spinal Pedicle Screw 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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