LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS— 510(k) K101730

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K101730 for LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS, Substantially Equivalent on 2010-12-03. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code KWZ
Advisory panel: Orthopedic
Date received: 2010-06-18
Decision date: 2010-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code KWZ

product code KWZ

Injury: 993
Total: 993

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.