SHIRAZ-JAVA SPINAL FIXATION SYSTEM— 510(k) K031265

Substantially Equivalent

Spine Next SA

FDA 510(k) clearance K031265 for SHIRAZ-JAVA SPINAL FIXATION SYSTEM, Substantially Equivalent on 2003-10-09. Applicant: Spine Next SA.

Clearance details

Applicant: Spine Next SA
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2003-04-21
Decision date: 2003-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Queenstown, MD, US

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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.