COSMOLOCK PEDICLE SCREW SYSTEM— 510(k) K140678

Substantially Equivalent

Kalitec Direct, LLC

FDA 510(k) clearance K140678 for COSMOLOCK PEDICLE SCREW SYSTEM, Substantially Equivalent on 2014-06-19. Applicant: Kalitec Direct, LLC.

Clearance details

Applicant: Kalitec Direct, LLC
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2014-03-18
Decision date: 2014-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, 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.