Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is S.H.Pitkar Orthotools Pvt. , Ltd.. It received FDA 510(k) clearance on 2020-07-29 under 510(k) 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. The listed applicant is S.H.Pitkar Orthotools Pvt. , Ltd.. The 510(k) number is K200518.

When did Pitkar External Fixation System - Rail Mechanism receive FDA 510(k) clearance?

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

Who is the listed applicant for Pitkar External Fixation System - Rail Mechanism?

The FDA 510(k) record lists S.H.Pitkar Orthotools Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing S.H.Pitkar Orthotools Pvt. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240233Pitkar Spinal Pedicle Screw SystemK200728Pitkar DeftFix SystemK192619Pitkar Locked Plating SystemK190486Pitkar External Fixation System

Related Devices (Code: KTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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.

↑