Pitkar DeftFix System— 510(k) K200728

Clearance details

Applicant

S.H.Pitkar Orthotools Pvt. , Ltd.

Product code

Product code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2020-03-20

Decision date

2020-10-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Pune, IN

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• K240233 — Pitkar Spinal Pedicle Screw System2024-09-09
• K200518 — Pitkar External Fixation System - Rail Mechanism2020-07-29
• K192619 — Pitkar Locked Plating System2020-02-27
• K190486 — Pitkar External Fixation System2019-10-16

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 →