ZIMMER BEADED THREADED ACETABULAR CUP— 510(k) K884658

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K884658 for ZIMMER BEADED THREADED ACETABULAR CUP, Substantially Equivalent on 1988-11-30. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 1988-11-07
Decision date: 1988-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.