AMSET PLD SYSTEM— 510(k) K905014

Substantially Equivalent

Advanced Med/Surg, Inc.

FDA 510(k) clearance K905014 for AMSET PLD SYSTEM, Substantially Equivalent on 1991-04-01. Applicant: Advanced Med/Surg, Inc..

Clearance details

Applicant: Advanced Med/Surg, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1990-11-06
Decision date: 1991-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, 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.