MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)— 510(k) K883661

Name: FDA 510(k) clearance K883661
Creator: U.S. Food and Drug Administration
Published: 1989-02-08

Substantially Equivalent for Some Indications

Depuy, Inc.

FDA 510(k) clearance K883661 for MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS), Substantially Equivalent for Some Indications on 1989-02-08. Applicant: Depuy, Inc.. Device class: 2.

Clearance details

Applicant: Depuy, Inc.
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1988-08-26
Decision date: 1989-02-08
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.