METAL BACKED ACETABULAR COMPONENT— 510(k) K950542

Name: FDA 510(k) clearance K950542
Creator: U.S. Food and Drug Administration
Published: 1995-05-25

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K950542 for METAL BACKED ACETABULAR COMPONENT, Substantially Equivalent on 1995-05-25. Applicant: Encore Orthopedics, Inc.. Device class: 3.

Clearance details

Applicant: Encore Orthopedics, Inc.
Product code: Code JDL
Device class: Class 3
Regulation: 21 CFR 888.3320
Advisory panel: Orthopedic
Date received: 1995-02-07
Decision date: 1995-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDL

product code JDL

Injury: 285
Total: 285

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.