Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads— 510(k) K173499

Substantially Equivalent

Stryker Orthopaedics

FDA 510(k) clearance K173499 for Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads, Substantially Equivalent on 2018-03-19. Applicant: Stryker Orthopaedics.

Clearance details

Applicant: Stryker Orthopaedics
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 2017-11-13
Decision date: 2018-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.