AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS— 510(k) K092419

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K092419 for AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS, Substantially Equivalent on 2009-09-01. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2009-08-06
Decision date: 2009-09-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Mahwah, NJ, 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.