MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM— 510(k) K081790

Substantially Equivalent

Trinity Orthopedics, LLC

FDA 510(k) clearance K081790 for MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM, Substantially Equivalent on 2008-07-24. Applicant: Trinity Orthopedics, LLC.

Clearance details

Applicant: Trinity Orthopedics, LLC
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2008-06-25
Decision date: 2008-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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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.