HIP PROSTHESIS -VARIOUS— 510(k) K831420

Name: FDA 510(k) clearance K831420
Creator: U.S. Food and Drug Administration
Published: 1983-09-20

Substantially Equivalent

The Oec Group

FDA 510(k) clearance K831420 for HIP PROSTHESIS -VARIOUS, Substantially Equivalent on 1983-09-20. Applicant: The Oec Group. Device class: 2.

Clearance details

Applicant: The Oec Group
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1983-05-03
Decision date: 1983-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K252326 — InterSpace GV Hip Spacer2025-08-06
K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12

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Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.