METAL BACKED ACETABULAR COMPONENT— 510(k) K821342

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K821342 for METAL BACKED ACETABULAR COMPONENT, Substantially Equivalent on 1982-05-21. Applicant: Intermedics Orthopedics.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1982-05-05
Decision date: 1982-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.