CERVICAL PLATE— 510(k) K042317

Substantially Equivalent

Scient'X

FDA 510(k) clearance K042317 for CERVICAL PLATE, Substantially Equivalent on 2004-09-24. Applicant: Scient'X.

Clearance details

Applicant: Scient'X
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2004-08-26
Decision date: 2004-09-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Rock, TX, 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.