ORTHOBIOM SPINAL SYSTEM— 510(k) K071668

Substantially Equivalent

Paradigm Spine

FDA 510(k) clearance K071668 for ORTHOBIOM SPINAL SYSTEM, Substantially Equivalent on 2008-07-02. Applicant: Paradigm Spine.

Clearance details

Applicant: Paradigm Spine
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2007-06-19
Decision date: 2008-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.