ENDOPEARL— 510(k) K984171

Substantially Equivalent

Linvatec Corp.

FDA 510(k) clearance K984171 for ENDOPEARL, Substantially Equivalent on 1999-04-29. Applicant: Linvatec Corp..

Clearance details

Applicant: Linvatec Corp.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 1998-11-20
Decision date: 1999-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

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Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.