ORTHOPEDIC CUSTOM SURGICAL KIT— 510(k) K844595

Substantially Equivalent

Xanmed Corp.

FDA 510(k) clearance K844595 for ORTHOPEDIC CUSTOM SURGICAL KIT, Substantially Equivalent on 1985-08-21. Applicant: Xanmed Corp..

Clearance details

Applicant: Xanmed Corp.
Product code: Code LXH
Advisory panel: Orthopedic
Date received: 1984-11-26
Decision date: 1985-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LXH

product code LXH

Death: 11
Injury: 2,218
Malfunction: 31,318
Total: 33,547

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.