MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS— 510(k) K912837

Substantially Equivalent

Kirschner Medical Corp.

FDA 510(k) clearance K912837 for MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS, Substantially Equivalent on 1992-08-26. Applicant: Kirschner Medical Corp..

Clearance details

Applicant: Kirschner Medical Corp.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1991-06-26
Decision date: 1992-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Timonium, MD, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.