LAGUNA SIZE 8 PEDICLE SCREW— 510(k) K072678

Substantially Equivalent

Allez Spine, LLC

FDA 510(k) clearance K072678 for LAGUNA SIZE 8 PEDICLE SCREW, Substantially Equivalent on 2008-07-02. Applicant: Allez Spine, LLC.

Clearance details

Applicant: Allez Spine, LLC
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2007-09-21
Decision date: 2008-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, 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.