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FDA 510(k)

Pitkar DeftFix System

K-Number: K200728 · 2020-10-06

ApplicantS.H.Pitkar Orthotools Pvt. , Ltd.
Decision Date2020-10-06
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pitkar DeftFix System is a medical device manufactured by S.H.Pitkar Orthotools Pvt. , Ltd.. It received FDA 510(k) clearance on 2020-10-06 under approval number K200728. 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 DeftFix System?

Pitkar DeftFix System is a medical device that received FDA 510(k) clearance on 2020-10-06. It is manufactured by S.H.Pitkar Orthotools Pvt. , Ltd.. The 510(k) number is K200728.

When was Pitkar DeftFix System approved by the FDA?

Pitkar DeftFix System received FDA 510(k) clearance on 2020-10-06, under approval number K200728.

What company makes Pitkar DeftFix System?

Pitkar DeftFix System is manufactured by S.H.Pitkar Orthotools Pvt. , Ltd..

What is the FDA product code for Pitkar DeftFix System?

The FDA product code for Pitkar DeftFix System is KTT.

Other Devices by S.H.Pitkar Orthotools Pvt. , Ltd.

K190486Pitkar External Fixation System K200518Pitkar External Fixation System - Rail Mechanism 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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