ANTERIOR BUTTRESS PLATE— 510(k) K081548

Substantially Equivalent

Scient'X USA, Inc.

FDA 510(k) clearance K081548 for ANTERIOR BUTTRESS PLATE, Substantially Equivalent on 2009-01-29. Applicant: Scient'X USA, Inc..

Clearance details

Applicant: Scient'X USA, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2008-06-02
Decision date: 2009-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maitland, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.