SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM— 510(k) K070295

Substantially Equivalent

Trinity Orthopedics, LLC

FDA 510(k) clearance K070295 for SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM, Substantially Equivalent on 2007-05-21. Applicant: Trinity Orthopedics, LLC.

Clearance details

Applicant: Trinity Orthopedics, LLC
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2007-01-31
Decision date: 2007-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
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.