SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN— 510(k) K862311

Clearance details

Applicant

Warsaw Orthopedic, Inc.

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

1986-06-17

Decision date

1986-07-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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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 →