VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS— 510(k) K120370

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K120370 for VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS, Substantially Equivalent on 2012-06-04. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code OQG
Advisory panel: Orthopedic
Date received: 2012-02-06
Decision date: 2012-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code OQG

product code OQG

Injury: 249
Total: 249

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.