VERTEFIX VERTEBROPLASTY PROCEDURE SET— 510(k) K042691

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K042691 for VERTEFIX VERTEBROPLASTY PROCEDURE SET, Substantially Equivalent on 2005-11-08. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2004-09-29
Decision date: 2005-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

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Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.