510(k) K091253— THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS

Substantially Equivalent

K2m, Inc.

Clearance details

Applicant: K2m, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2009-04-29
Decision date: 2009-06-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, US

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.