UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS— 510(k) K031381

Substantially Equivalent

Seaspine

FDA 510(k) clearance K031381 for UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS, Substantially Equivalent on 2003-07-30. Applicant: Seaspine.

Clearance details

Applicant: Seaspine
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2003-05-01
Decision date: 2003-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.