OSTEOMED HAND FUSION SYSTEM— 510(k) K111419

Substantially Equivalent

Osteomed LP

FDA 510(k) clearance K111419 for OSTEOMED HAND FUSION SYSTEM, Substantially Equivalent on 2011-10-07. Applicant: Osteomed LP.

Clearance details

Applicant: Osteomed LP
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2011-05-20
Decision date: 2011-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.