510(k) K190486— Pitkar External Fixation System

Substantially Equivalent

S.H.Pitkar Orthotools Pvt. , Ltd.

Clearance details

Applicant: S.H.Pitkar Orthotools Pvt. , Ltd.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2019-02-28
Decision date: 2019-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pune, IN

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.