Pitkar Locked Plating System— 510(k) K192619

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..

Clearance details

Applicant: S.H.Pitkar Orthotools Pvt. , Ltd.
Product code: Code HRS
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 ↗

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.