ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES— 510(k) K992621

Substantially Equivalent

Advanced Diagnostics & Interventions

FDA 510(k) clearance K992621 for ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES, Substantially Equivalent on 1999-11-08. Applicant: Advanced Diagnostics & Interventions.

Clearance details

Applicant
Advanced Diagnostics & Interventions
Product code
Code HRX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Redondo Beach, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HRX

product code HRX
Injury
623
Malfunction
11,257
Total
11,880

Source: openFDA MAUDE database, through . 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.