ARTHRO-SURGIMAT-2000 ECU— 510(k) K990443

Substantially Equivalent

W.O.M. World of Medicine GmbH

FDA 510(k) clearance K990443 for ARTHRO-SURGIMAT-2000 ECU, Substantially Equivalent on 1999-02-26. Applicant: W.O.M. World of Medicine GmbH.

Clearance details

Applicant: W.O.M. World of Medicine GmbH
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1999-02-11
Decision date: 1999-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Mansfield, MA, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.