PM CEMENTLESS SCREW-IN ACETABULAR CUP— 510(k) K850773

Name: FDA 510(k) clearance K850773
Creator: U.S. Food and Drug Administration
Published: 1985-05-02

Substantially Equivalent

Advanced Biosearch Assn.

FDA 510(k) clearance K850773 for PM CEMENTLESS SCREW-IN ACETABULAR CUP, Substantially Equivalent on 1985-05-02. Applicant: Advanced Biosearch Assn.. Device class: 3.

Clearance details

Applicant: Advanced Biosearch Assn.
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 1985-02-25
Decision date: 1985-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danville, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.