G7® Vivacit-E® Freedom® Constrained Liner— 510(k) K212512

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K212512 for G7® Vivacit-E® Freedom® Constrained Liner, Substantially Equivalent on 2022-04-28. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code PBI
Advisory panel: Orthopedic
Date received: 2021-08-10
Decision date: 2022-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code PBI

product code PBI

Injury: 499
Malfunction: 729
Total: 1,228

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.