ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES— 510(k) K102743

Clearance details

Applicant

Ortho Solutions Limited

Product code

Code HWE

Device class

Class 1

Regulation

21 CFR 878.4820

Advisory panel

General, Plastic Surgery

Date received

2010-09-22

Decision date

2011-01-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Prior Lake, MN, US

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Death

4

Injury

448

Malfunction

19,856

Other

2

Total

20,310

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 →