ABC CERVICAL PLATING SYSTEM— 510(k) K000486

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K000486 for ABC CERVICAL PLATING SYSTEM, Substantially Equivalent on 2000-04-14. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2000-02-14
Decision date: 2000-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, 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.