MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM— 510(k) K024313

Substantially Equivalent

Pisharodi Surgicals, Inc.

FDA 510(k) clearance K024313 for MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM, Substantially Equivalent on 2003-08-29. Applicant: Pisharodi Surgicals, Inc..

Clearance details

Applicant: Pisharodi Surgicals, Inc.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2002-12-24
Decision date: 2003-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Rock, TX, 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.