ARCHON ANTERIOR CERVICAL PLATE SYSTE,— 510(k) K122910

Substantially Equivalent

Nu Vasive, Incorporated

FDA 510(k) clearance K122910 for ARCHON ANTERIOR CERVICAL PLATE SYSTE,, Substantially Equivalent on 2012-10-11. Applicant: Nu Vasive, Incorporated.

Clearance details

Applicant: Nu Vasive, Incorporated
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2012-09-21
Decision date: 2012-10-11
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, 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.