Seneka II Polyscrew Pedicle Fixation System— 510(k) K153525

Substantially Equivalent

Senecka Spine

FDA 510(k) clearance K153525 for Seneka II Polyscrew Pedicle Fixation System, Substantially Equivalent on 2016-01-28. Applicant: Senecka Spine.

Clearance details

Applicant: Senecka Spine
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2015-12-09
Decision date: 2016-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Johnson City, NY, 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.