MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO— 510(k) K912205

Substantially Equivalent

Microaire

FDA 510(k) clearance K912205 for MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO, Substantially Equivalent on 1991-08-16. Applicant: Microaire.

Clearance details

Applicant: Microaire
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1991-05-20
Decision date: 1991-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, 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.