THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS— 510(k) K081380

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K081380 for THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS, Substantially Equivalent on 2008-11-19. Applicant: K2m, Inc..

Clearance details

Applicant: K2m, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2008-05-16
Decision date: 2008-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

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.