Pitkar Locked Plating System— 510(k) K192619

Name: FDA 510(k) clearance K192619
Creator: U.S. Food and Drug Administration
Published: 2020-02-27

Substantially Equivalent

S.H.Pitkar Orthotools Pvt. , Ltd.

FDA 510(k) clearance K192619 for Pitkar Locked Plating System, Substantially Equivalent on 2020-02-27. Applicant: S.H.Pitkar Orthotools Pvt. , Ltd.. Device class: 2.

Clearance details

Applicant: S.H.Pitkar Orthotools Pvt. , Ltd.
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2019-09-23
Decision date: 2020-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pune, IN

Download summary PDF View on FDA.gov ↗

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K262098 — EnHAnce PEEK Bunion System2026-09-18
K262963 — TMC Implant Fixation System2026-09-15

More clearances from S.H.Pitkar Orthotools Pvt. , Ltd.

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K240233 — Pitkar Spinal Pedicle Screw System2024-09-09
K200728 — Pitkar DeftFix System2020-10-06
K200518 — Pitkar External Fixation System - Rail Mechanism2020-07-29
K190486 — Pitkar External Fixation System2019-10-16

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.