PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems— 510(k) K182473

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K182473 for PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems, Substantially Equivalent on 2018-12-12. Applicant: K2m, Inc..

Clearance details

Applicant: K2m, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2018-09-10
Decision date: 2018-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, US

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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.