Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System— 510(k) K151648

Substantially Equivalent

Altus Partners, LLC

FDA 510(k) clearance K151648 for Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System, Substantially Equivalent on 2015-10-16. Applicant: Altus Partners, LLC.

Clearance details

Applicant: Altus Partners, LLC
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2015-06-18
Decision date: 2015-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newtown Square, PA, 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.