ARTHRO AUTOMAT 5002— 510(k) K871180

Substantially Equivalent

F.M. Wiest USA, Inc.

FDA 510(k) clearance K871180 for ARTHRO AUTOMAT 5002, Substantially Equivalent on 1987-09-29. Applicant: F.M. Wiest USA, Inc..

Clearance details

Applicant: F.M. Wiest USA, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1987-03-25
Decision date: 1987-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cherry Hill, NJ, US

Download summary PDF View on FDA.gov ↗

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.