ARTHRO-SURGIMAT-1500— 510(k) K983910

Name: FDA 510(k) clearance K983910
Creator: U.S. Food and Drug Administration
Published: 1998-11-25

Substantially Equivalent

W.O.M. World of Medicine GmbH

FDA 510(k) clearance K983910 for ARTHRO-SURGIMAT-1500, Substantially Equivalent on 1998-11-25. Applicant: W.O.M. World of Medicine GmbH. Device class: 2.

Clearance details

Applicant: W.O.M. World of Medicine GmbH
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 1998-11-03
Decision date: 1998-11-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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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.