DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins MR Conditional, DePuy Synthes Variable Angle Positioning Pins MR Conditional, DePuy Synthes Wire Mount MR Conditional, DePuy Synthes Cerclage Positioning Pin MR Conditional— 510(k) K172975

Clearance details

Applicant

Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

Product code

Product code JDQ

Device class

Class 2

Regulation

21 CFR 888.3010

Advisory panel

Orthopedic

Date received

2017-09-27

Decision date

2018-06-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

West Chester, PA, US

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Death

9

Injury

330

Total

339

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 →