FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System— 510(k) K162446

Substantially Equivalent

Orthofix, Inc.

FDA 510(k) clearance K162446 for FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System, Substantially Equivalent on 2016-12-22. Applicant: Orthofix, Inc..

Clearance details

Applicant: Orthofix, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2016-09-01
Decision date: 2016-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewisville, TX, US

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Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.