ORION ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K973854

Substantially Equivalent for Some Indications

Sofamor Danek USA,Inc.

FDA 510(k) clearance K973854 for ORION ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent for Some Indications on 1998-03-16. Applicant: Sofamor Danek USA,Inc..

Clearance details

Applicant: Sofamor Danek USA,Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1997-10-03
Decision date: 1998-03-16
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, 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.