PREFERENCE PEDICLE SCREW SYSTEM— 510(k) K081296

Substantially Equivalent

Us Spine

FDA 510(k) clearance K081296 for PREFERENCE PEDICLE SCREW SYSTEM, Substantially Equivalent on 2008-06-06. Applicant: Us Spine.

Clearance details

Applicant: Us Spine
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2008-05-07
Decision date: 2008-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Apple Valley, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.