Pantheon Pedicle Screw and Iliac Bolt Fixation System— 510(k) K241494

Substantially Equivalent

Pantheon Spinal

FDA 510(k) clearance K241494 for Pantheon Pedicle Screw and Iliac Bolt Fixation System, Substantially Equivalent on 2024-07-26. Applicant: Pantheon Spinal.

Clearance details

Applicant: Pantheon Spinal
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2024-05-28
Decision date: 2024-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Georgetown, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.